Sehr gute long Investment Chance

berliner......

Dies sieht ja richtig gut aus.

Sehr gute Recherche.....

Meinst Du, die kommt die nächsten Tage noch etwas runter?

aber vielleicht hast Du ja auch eine Meinung dazu?

die q4 zahlen, welche noch besser ausfallen dürfte als q3.
für q1 2013 gibt es durch den vertrag mit OrbeShield weitere einnahmen.
es gibt nur ca. 12 mio aktien, vergleichbare werte wie PEREGRINE PHARMACEUTICALS sind deutlich mehr wert. ca. 2 us dollar bei bei ca. 132 mio aktien.
das heißt hier nun echtes potenzial.

gab es ein investoer der zu 1,34 100t aktien wollte, er bekam 10T denn zu 1,34 standen noch 90T nachdem 20T einglöst wurden. wenn hier noch pusherblätter kommen stehen wir schnell bei 5 bis 10 usdollar. was gerade mal 50 bis 100 mio us dollar mk wären. also nichts für solch ein wert peregrine ist 200 mio wert.

noch hat der investor nicht gekauft, sondern wartet auf gewinnmitnehmer, immer noch eine sehr gute einstiegschance

Diese Woche dürfte da wohl noch mehr Schwung rein kommen

 Läuft sehr gut heute.  Leider habe ich keine. :/

durch nen glücklichen Zufall nen Tag vor dem Crash verkauft und dann als sie unten war  wieder zurück gekauft.

meine meinung

 Was spricht denn dafür.  Also für nicht zocker und kleinanleger.

Überlege aber mir fehlt noch der bezug. *denk*

sehr gut sogar

50 über 100er, 100er über 200er... zahlenentwicklung passt

http://www.ariva.de/news/...l-Acute-Radiation-Syndrome-GI-ARS-4418331

"There are no FDA approved therapies for the treatment of GI ARS," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. "The FDA's action in granting fast track designation is a validation of BDP's potential to address this life-threatening, unmet medical need. We look forward to working closely with the FDA, as well as with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to potentially expedite the OrbeShieldTM development program."

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs. In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days. The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI. Although the hematopoietic syndrome has the potential to be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that results from high-dose radiation exposure. Therefore, there is an urgent need to develop specific medical countermeasures against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShieldTM

OrbeShieldTM contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. OrbeShieldTM is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract and the other tablet is intended to release BDP in the distal portions of the GI tract. BDP has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. Oral BDP may also have application in treating other GI disorders characterized by severe inflammation such as Crohn's disease and radiation enteritis.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec�), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral Mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax(TM), which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax(TM), a vaccine against anthrax exposure. RiVax(TM) has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax(TM) and VeloThrax(TM) are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax(TM). Soligenix is also developing OrbeShield(TM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShieldTM has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCE Soligenix, Inc.



www.prnewswire.com


übersetzt mit google


FDA Grants Soligenix Fast Track Designation für OrbeShield (TM) für die Reduktion der Mortalität mit gastrointestinalen akuten Strahlenkrankheit Syndrom (GI ARS) Assoziierte

PRINCETON, NJ, 29. Januar 2013 / PRNewswire / - Soligenix, Inc. (OTCQB: SNGX) (Soligenix oder das Unternehmen), eine Entwicklung, biopharmazeutisches Unternehmen, gab heute bekannt, dass seine OrbeShieldTM (oral Beclometason 17,21 - dipropionate oder mündliche BDP) Entwicklungsprogramm für die Behandlung von GI ARS hat "Fast Track" von der US Food and Drug Administration (FDA) erhalten. Soligenix hat ebenfalls zuvor Orphan Drug von der FDA für die orale BDP erhielten zur Vorbeugung des Todes infolge einer potentiell tödlichen Dosis von Ganzkörperbestrahlung während oder nach einer Bestrahlung Katastrophe.
Fast Track ist eine Bezeichnung, dass die FDA Reserven für ein Medikament soll einen schweren oder lebensbedrohlichen Zustand und eine, die das Potenzial für einen ungedeckten medizinischen Bedarf für den Zustand adressieren zeigt behandeln. Fast-Track-wurde entwickelt, um die Entwicklung erleichtert und beschleunigt die Prüfung neuer Arzneimittel. Zum Beispiel sollte Veranstaltungen rechtfertigen, wird Soligenix Anspruch auf eine New Drug Application (NDA) für OrbeShieldTM auf einer kontinuierlichen Basis vorlegen, erlaubt die FDA Teile der NDA bereits vor dem Eingang der vollständigen Unterwerfung. Zusätzlich NDAs für schnelle Spur Entwicklungsprogramme für gewöhnlich kommen für Priority-Review, die eine verkürzte Zeit für die Prüfung von sechs Monaten vermittelt.

"Es gibt keine von der FDA zugelassenen Therapien zur Behandlung von GI ARS", sagte Christopher J. Schaber, PhD, President & Chief Executive Officer von Soligenix. "Die FDA-Aktion bei der Gewährung Fast-Track ist eine Validierung der BDP das Potenzial, diese lebensbedrohlich, nicht gedeckten medizinischen Bedarf adressieren. Wir freuen uns auf die enge Zusammenarbeit mit der FDA, sowie mit dem National Institute of Allergy and Infectious Disease (NIAID ) und der Biomedical Advanced Research and Development Authority (BARDA) potenziell beschleunigen die OrbeShieldTM Entwicklungsprogramm. "

Über GI ARS

ARS tritt nach toxischen Strahlenbelastung und umfasst mehrere Organsysteme, insbesondere das Knochenmark der GI-Trakt und später die Lunge. Im Falle einer nuklearen Katastrophe oder terroristische Detonation einer Atombombe sind Opfer ausgesetzt> 2 Gy mit einem hohen Risiko für die Entwicklung einer klinisch signifikanten ARS. Exposition gegenüber hohen Dosen von Strahlung von mehr als 10-12 Gy verursacht akute GI Verletzungen, die zum Tod in 5-15 Tagen führen kann. Der GI-Trakt ist hochempfindlich aufgrund der Anforderung für unaufhörlichen Proliferation von Stammzellen und Krypta Herstellung von Schleimhautepithel. Das Ausmaß der Schädigung des Knochenmarks und der GI-Trakt sind die wichtigsten Determinanten des Überlebens nach der Exposition gegenüber TBI. Obwohl die hämatopoetischen Syndrom hat das Potential, durch Knochenmarkstransplantation oder Wachstumsfaktor Verabreichung gerettet werden, gibt es keine etablierte Behandlung oder vorbeugenden Maßnahme zur GI Schäden infolge hochdosierten Strahlenexposition. Daher ist es dringend notwendig ist, bestimmte medizinische Gegenmaßnahmen gegen die tödliche pathophysiologischen Manifestationen der strahleninduzierten GI Verletzungen entwickeln.

Über OrbeShieldTM

OrbeShieldTM enthält BDP, ein hochwirksamer, topisch wirksamen Kortikosteroiden, die eine lokale Wirkung auf entzündete Gewebe hat. OrbeShieldTM ist zur oralen Verabreichung in GI ARS Patienten als einheitliches Produkt aus zwei Tabletten formuliert; eine Tablette soll BDP in den proximalen Abschnitten des GI-Trakts und der andere Tablette freigeben soll BDP in den distalen Abschnitten des Magen freisetzen Trakt. BDP hat in den Vereinigten Staaten und weltweit seit den frühen 1970er Jahren als pharmazeutischen Wirkstoff in Inhalations-Produkte für die Behandlung von Patienten mit allergischer Rhinitis und Asthma vermarktet. Oral BDP kann auch Anwendung bei der Behandlung anderer Erkrankungen, die durch GI schwere Entzündungen wie Morbus Crohn und Strahlenenteritis charakterisiert.

Über Soligenix, Inc.

Soligenix ist eine Entwicklung biopharmazeutisches Unternehmen die Entwicklung von Produkten zu schweren entzündlichen Erkrankungen zu behandeln, wo es bleibt ein ungedeckter medizinischer Bedarf, sowie die Entwicklung von mehreren Biodefense Impfstoffe und Therapeutika. Soligenix entwickelt proprietären Rezepturen der mündlichen BDP (Beclometason 17,21-Dipropionat) für die Prävention / Behandlung von Magen-Darm-Erkrankungen, die durch eine starke Entzündung, einschließlich pädiatrischer Morbus Crohn (SGX203), akute Strahlung Enteritis (SGX201) und chronische Graft-versus-Host gekennzeichnet Krankheit (orBec), sowie die Entwicklung seines neuartigen angeborenen Abwehr Regler (IDR) Technologie SGX942 für die Behandlung von oraler Mukositis.

Durch seine Biodefense Division, wird Soligenix entwickeln Gegenmaßnahmen nach dem Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan 2011-2016 für die Aufnahme in die US-Regierung Strategischen Nationalen Stockpile. Soligenix führendes Biodefense Produkte in der Entwicklung sind ein rekombinanter Subunit-Impfstoff namens RiVax (TM), die zum Schutz gegen die tödliche Auswirkungen der Exposition gegenüber Ricintoxin und VeloThrax (TM), ein Impfstoff gegen Anthrax Exposition zu schützen. RiVax (TM) hat sich gezeigt, dass gut verträglich und immunogen in zwei klinischen Phase-1-Studien an gesunden Freiwilligen. Beide RiVax (TM) und VeloThrax (TM) sind derzeit Gegenstand einer $ 9.400.000 National Institute of Allergy and Infectious Diseases (NIAID) Förderpreis Entwicklung neuer Impfstoff Soligenix die thermische Stabilisierung Technologie ThermoVax (TM) bekannt. Soligenix ist auch die Entwicklung OrbeShield (TM) für die Behandlung von Magen-Darm akuten Strahlenkrankheit Syndrom (GI ARS) unter $ 600.000 NIAID Small Business Innovation Research (SBIR) Zuschuss. OrbeShieldTM zuvor statistisch signifikante präklinische Überleben Ergebnisse in zwei getrennten canine GI ARS Studien des NIH finanziert demonstriert.

Für weitere Informationen bezüglich Soligenix, Inc., besuchen Sie bitte die Website des Unternehmens unter www.soligenix.com.

Diese Pressemitteilung enthält zukunftsgerichtete Aussagen, die Soligenix, Inc. 's aktuelle Erwartungen bezüglich ihrer zukünftigen Ergebnissen, Leistungen, Aussichten und Möglichkeiten anzupassen. Aussagen, die keine historischen Fakten sind, wie "antizipieren", "glauben", "beabsichtigen" oder ähnliche Ausdrücke enthalten, sind zukunftsweisende Aussagen. Diese Aussagen unterliegen einer Reihe von Risiken, Unsicherheiten und andere Faktoren, aufgrund derer die tatsächlichen Ereignisse oder Ergebnisse in zukünftigen Perioden wesentlich von den in ausgedrückt oder impliziert werden, diesen Aussagen abweichen. Soligenix kann nicht versichern, dass es in der Lage sein, erfolgreich zu entwickeln oder Vermarktung von Produkten auf der eigenen Technologie basiert, insbesondere in Anbetracht der erheblichen Unsicherheit in der Entwicklung von Impfstoffen gegen Bioterror Bedrohungen, Herstellung und Durchführung von präklinischen und klinischen Studien von Impfstoffen und Erlangung der behördlichen Genehmigungen, , dass die Produktentwicklung und Kommerzialisierung Bemühungen nicht reduziert oder abgesetzt werden aufgrund von Schwierigkeiten oder Verzögerungen bei der klinischen Studien oder aufgrund mangelnder Fortschritt oder positive Ergebnisse aus Forschung und Entwicklung, dass es in der Lage sein, erfolgreich zu erhalten, weitere Stipendien und Auszeichnungen, halten wird bestehenden Zuschüssen, die abhängig von den Leistungsparametern sind, in allen Biodefense Aufträge mit der US-Regierung oder anderen Ländern geben, oder dass der US-Kongress nicht passieren jede Gesetzgebung, die zusätzliche Finanzierung für das Projekt BioShield Programm würde. Diese und andere Risikofaktoren werden von Zeit zu Zeit in den Einreichungen bei der Securities and Exchange Commission, einschließlich beschrieben, aber nicht beschränkt auf, Soligenix Bericht auf den Formularen 10-Q und 10-K begrenzt. Soweit nicht gesetzlich vorgeschrieben, übernimmt Soligenix keine Verpflichtung zur Aktualisierung oder Überprüfung zukunftsgerichteter Aussagen infolge neuer Informationen oder künftiger Ereignisse weiterzuentwickeln.

SOURCE Soligenix, Inc.

:)

news verdauen und morgen gehts weiter.

RSI bei 90

der hammer ich hätt nicht gedacht das wie 2 dollar auf wochenschluss stehen. es ist wie es ist... 20 mio dollar mk ist auch eigentlich nichts bei den aussichten. eher wie ein pennystock von der bewertung

"We are pleased to be able to attract such esteemed and enthusiastic professionals to participate as members of our Medical Advisory Board," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The initiation of an oral mucositis program marks the first step in the development of our IDR technology platform. We look forward to working with the MAB and initiating a clinical program in 2013."

The MAB Members

Stephen T. Sonis, DMD, DMSc

Dr. Sonis currently serves as Clinical Professor of Oral Medicine at Harvard School of Dental Medicine and Senior Surgeon and Chief, Divisions of Oral Medicine at Brigham and Women's Hospital and the Dana-Farber Cancer Institute, and as Chief Scientific Officer, Biomodels, LLC. He also serves as a consultant to a number of biotechnology and pharmaceutical companies, advising directly on the conduct of clinical trials of oral mucositis. Throughout his career, Dr. Sonis has focused on the biology and clinical significance of cancer regimen-related mucosal toxicities. In particular, Dr. Sonis was pivotal in identifying the crucial role of innate immunity in the generation of severe oral mucositis. The results of his studies have provided treatment targets for biological and pharmaceutical development. Dr. Sonis and his collaborators have identified specific pathways that are critical in toxicity development and have used these to form the basis for models of gene-based risk prediction. Dr. Sonis has published and lectured extensively on the clinical, biological, and health economic aspects of cancer and complications associated with its treatment. He serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology. Dr. Sonis received his Doctor of Dental Medicine (DMD) from Tufts University, his Doctor of Medical Science (DMSc) from Harvard University and was a Knox Fellow at Oxford University.

Dorothy Keefe, MD, FRACP, FRCP

Professor Keefe is Service Director, SA Cancer Services, Professor of Cancer Medicine at the University of Adelaide and a Senior Medical Oncologist at Royal Adelaide Hospital Cancer Centre. She is Head of the Mucositis Research Group in the Hanson Institute, and Immediate Past-President of the Multi-national Association of Supportive Care in Cancer (MASCC). Professor Keefe's research interests include mucositis in its broadest sense, covering patho-biology, epidemiology, prevention and treatment. She has been highly involved in leading the development of evidence-based guidelines for the management of mucositis through MASCC, as well as co-chairing an international, multi-centre study investigating burden of illness and cost of care for patients with mucositis. Professor Keefe graduated in Medicine (Bachelor of Medicine, Bachelor of Surgery; MBBS) from the University of London. She migrated to Australia, where she undertook her Physician Training in General Medicine and Medical Oncology at the Queen Elizabeth Hospital in South Australia. She became a Fellow of the Royal Australasian College of Physicians (FRACP) and later a Fellow of the Royal College of Physicians in London (FRCP). She received her Doctorate of Medicine from the University of Adelaide.

Mark Schubert, DDS, MSD

Dr. Schubert is a Professor in the Department of Oral Medicine, School of Dentistry at the University of Washington and is the Director of Oral Medicine with the Seattle Cancer Care Alliance as well as a Member in the Clinical Research Division at the Fred Hutchinson Cancer Research Center. Dr. Schubert's research interests have focused on the oral complications of cancer and cancer therapy, especially as they relate to hematopoietic cell transplantation. A primary area of interest has been the management of oral mucositis associated with cancer therapy. Research in oral mucositis management has focused on topical anti-infectives (defensins), growth factors and cytokines (KGFs and IL-11), cytoprotective agents (benzydamine, amifostine), and low level lasers therapy. Additional research interests include basic research and management strategies for other oral complications of cancer therapy including salivary gland dysfunction, oral graft-versus-host disease in allogeneic hematopoietic cell transplant recipients, and dental growth and development problems following hematopoietic cell transplant. Additionally, Dr. Schubert has been involved with research related to oral changes and infections in HIV-infected patients. Dr. Schubert received his Doctor of Dental Surgery from the University of Washington, where he completed a residency in Hospital Dentistry, and later received his Masters of Dental Sciences degree from the University of Washington.

About SGX942

SGX94 is an IDR, a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation-therapy. SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections. SGX94 is the subject of an open Investigational New Drug (IND). SGX94 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development inclusive of government grants.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies (e.g., radiation or chemotherapy). It can occur in any mucosal region, but is most commonly associated with the mouth (i.e., oral mucositis), followed by the small intestine. Mucositis affects 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis almost always occurs in patients with head and neck cancer treated with radiation therapy (>80% incidence of severe mucositis) and is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of mucositis depends greatly on the nature of the conditioning regimen used. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes. Direct and indirect consequences of mucositis have been estimated to add ~$18,000 per patient to cancer treatment costs.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec�), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral Mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax(TM), which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax(TM), a vaccine against anthrax exposure. RiVax(TM) has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax(TM) and VeloThrax(TM) are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax(TM). Soligenix is also developing OrbeShield(TM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShieldTM has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCE Soligenix, Inc.


rt.prnewswire.com/...NEWS_USPR_____PH53129&DateId=20130204

gute einsteigschance meiner meinung, oder nachlegen. muss jeder selbst entscheiden

bollingerband zieht nach oben

Die Biomedical Advanced Research and Development Authority

Die Biomedical Advanced Research and Development Authority ist die Komponente des Public Health Emergency Medical Countermeasures Enterprise, die auf der fortschrittlichen Entwicklung, Herstellung und Beschaffung von medizinischen Gegenmaßnahmen gegen chemische, biologische, radiologische und nukleare (CBRN) Bedrohungen Grippepandemie konzentriert und neu auftretender Krankheiten. BARDA Mitarbeiter sind Experten in den Bereichen der physikalischen, chemischen und biologischen Wissenschaften, Technik, klinische Medizin, Public Health, Produkt Entwicklung, Regulatory Affairs und Programm-Management.

Akute Radiation Syndrom

Akute Radiation Syndrom ( ARS ) (manchmal als Strahlung Toxizität oder Strahlenkrankheit bekannt) ist eine akute Erkrankung, die durch Bestrahlung des gesamten Körpers (oder das meiste des Körpers) von einer hohen Dosis durchdringender Strahlung verursacht in einem sehr kurzen Zeitraum (üblicherweise eine Sache von Minuten). Die Hauptursache für dieses Syndroms ist Erschöpfung der unreifen parenchymatösen Stammzellen in bestimmten Geweben. Beispiele von Menschen, die von ARS gelitten haben, sind die Überlebenden des Hiroshima und Nagasaki Atombomben, die Feuerwehrleute, die erst nach dem Kernkraftwerk Tschernobyl Veranstaltung in 1986, und einige unbeabsichtigte Exposition der Sterilisation Strahler reagiert. Die drei klassischen Syndrome sind:

• Knochenmark Syndrom : (manchmal als hämatopoetische Syndrom bezeichnet) vollständiger Syndroms wird üblicherweise mit einer Dosis zwischen 0,7 und 10 Gy (70 bis 1000 rads) auftreten, obwohl leichte Symptome so niedrig wie 0,3 Gy bzw. 30 rads4 auftreten können.

◦ Die Überlebensrate von Patienten mit diesem Syndrom nimmt mit steigender Dosis ab. Die primäre Ursache des Todes ist die Zerstörung des Knochenmarks, was zu Infektionen und Blutungen.

• Gastrointestinal (GI)-Syndrom : Die volle Syndrom wird in der Regel mit einer Dosis von mehr als etwa 10 Gy (1000 rad) auftreten, obwohl einige Symptome so niedrig wie 6 Gy oder 600 rads auftreten können.

◦ Überleben ist äußerst unwahrscheinlich, mit diesem Syndrom. Zerstörende und irreparable Veränderungen im Verdauungstrakt und Knochenmark verursachen in der Regel Infektionen, Dehydrierung und Elektrolyt-Ungleichgewicht. Der Tod tritt meist innerhalb von 2 Wochen.

• Herz-Kreislauf / Central Nervous System-Syndrom : Die volle Syndrom wird in der Regel mit einer Dosis von mehr als etwa 50 Gy (5000 rad) auftreten, obwohl einige Symptome so niedrig wie 20 Gy oder 2000 rads auftreten können.

◦ Der Tod tritt innerhalb von 3 Tagen. Tod wahrscheinlich auf des Kreislaufsystems sowie erhöhte Druck in der begrenzenden Schädeldach als Folge der erhöhten Flüssigkeitsgehalt von Ödemen, Vaskulitis, und Meningitis verursacht zusammenbrechen.

Anleger, die gerne in Biotech-Unternehmen, die Arzneimittel entwickeln, gegen ARS sind zu investieren haben mehrere Möglichkeiten in der US-Biotech-Markt. Ich werde Ihnen vorstellen drei Unternehmen, die es wert Investitionen vorangetrieben werden können. Mein Hauptaugenmerk wird Soligenix sein, weil ich denke, ihre Aussichten auf eine Bereitstellung einer erheblichen Return on Investment, da ihre aktuelle Marktkapitalisierung, sind extrem stark.

Soligenix

Soligenix, Inc. ist ein in der klinischen Phase biopharmazeutisches Unternehmen, das auf die Entwicklung von Produkten, um die Nebenwirkungen der Krebsbehandlung und schwerwiegende gastrointestinale Erkrankungen, bei denen es bleibt ein ungedeckter medizinischer Bedarf besteht, sowie die Entwicklung von mehreren Biodefense Impfstoffe und Therapeutika zu behandeln konzentriert.

Das Unternehmen unterhält zwei aktive Segmente: BioTherapeutics and Vaccines / Abwehr von Biowaffen. Soligenix die BioTherapeutics Geschäftsfeld will mündlichen Beclomethasondipropionat (oral BDP) für Indikationen wie pädiatrischen Morbus Crohn und akuter Strahlenkrankheit Enteritis sowie SGX942, ein Roman angeborenen Abwehr Regler-Technologie für orale Mukositis und verschiedene Infektionskrankheiten Anwendungen zu entwickeln. The Vaccines / Biodefense Geschäftsfeld umfasst die Entwicklung Programme für RiVax ™, einer Ricin-Toxin-Impfstoff, VeloThrax ™, einem Anthrax-Impfstoff und OrbeShield ™, ein Magen-Darm akuten Strahlenkrankheit Syndrom ("GI ARS") Therapeutikum, das zu erholen deutlich an Dynamik innerhalb erscheint die verschiedenen Regierungsstellen: National Institute of Allergy and Infectious Diseases (NIAID), Barda und FDA.

Soligenix ist ein relativ neuer Spieler in der ARS-Arena. Zu Beginn dieses Jahres hatte BARDA das Unternehmen informiert, dass nach sorgfältiger Analyse und Prüfung, wurde eingeladen Soligenix eine vollständige Vertrag Vorschlag für eine mögliche mehrjährige, Multi-Millionen-Dollar-Vertrag vorzulegen OrbeShield ™ von ihrem derzeitigen Niveau von Entwicklung technischen Bereitschaft zur FDA-Zulassung. Während ich dies schreibe, Soligenix hat diesen Vertrag Vorschlag BARDA vorgelegt, siehe Pressemitteilung .

OrbeShield ™ (ein orales sofortiger und verzögerter Freisetzung des topisch aktiven Corticosteroids BDP) wird für die Behandlung von GI ARS entwickelt. Corticosteroide sind die besten verstanden und am weitesten verbreitete Klasse von entzündungshemmenden Arzneimitteln. BDP ein Corticosteroid mit vorherrschend topische Aktivität im GI-Trakt, die bereits im Aerosol und Inhalationstor Form zur Verwendung bei Asthma und allergischer Rhinitis zugelassen ist.

In einem Hunde-Modell GI ARS zeigten OrbeShield ™ einen statistisch signifikanten Überlebensvorteil bei Tieren, die OrbeShield ™ Therapie erhalten bis zu 24 Stunden nach Exposition mit tödlichen Dosen von Ganzkörperbestrahlung ( TBI ) bei mit Placebo Kontrolltieren (p = 0,04) im Vergleich . Die mediane Überlebenszeit nach TBI Exposition in der Kontrollgruppe betrug 8 Tage, verglichen mit 87 Tagen im OrbeShield ™ behandelten Gruppe. Eine weitere Studie zu replizieren und nach den Beobachtungen in der Hunde-Modell vorgenommen ausbauen wird initiiert und, wie die früheren Studie wird durch eine aktuelle Small Business Innovation Research (SBIR) Gewährung von Finanzhilfen von $ 600.000 unterstützt.

Am 29. Januar hat die FDA gewährte Soligenix "Fast Track"-Bezeichnung für OrbeShield ™ zur Reduktion der Mortalität im Zusammenhang mit GI ARS verbunden. Das Unternehmen hat auch zuvor IND-Clearance und Orphan Drug Designation von der FDA erhielt für mündliche BDP zur Prävention von Tod nach einer potentiell tödlichen Dosis von Ganzkörperbestrahlung während oder nach einer Bestrahlung Katastrophe.

Fast Track ist eine Bezeichnung, dass die FDA Reserven für ein Medikament soll einen schweren oder lebensbedrohlichen Zustand und eine, die das Potenzial für einen ungedeckten medizinischen Bedarf für den Zustand adressieren zeigt behandeln. Fast-Track-wurde entwickelt, um die Entwicklung erleichtert und beschleunigt die Prüfung neuer Arzneimittel.

Die wichtigsten ARS Wettbewerbern

Cleveland BioLabs, Inc .

Cleveland Biolabs ( CBLI ) ist ein in der klinischen Phase Biotechnologie-Unternehmen mit einem Schwerpunkt auf Onkologie und Orphan-Drug-Entwicklung. Seit der Gründung im Jahr 2003 hat das Unternehmen die Forschung, Entwicklung und Vermarktung von eigenen Produkten, die das Potenzial zur Behandlung von Krebs haben, Vorbeugung und Behandlung von akuten Strahlenkrankheit Syndrom und entgegen der toxischen Wirkungen von Radio-und Chemotherapie für Krebspatienten verfolgt.

Derzeit haben sie neun Produkt-Kandidaten in der Pipeline. Ihre wichtigste Produkt in der Entwicklung gegen ARS, die derzeit von einem $ 45.000.000 Auftragsvergabe in 2010 unterstützt wird, ist Entolimod ™ (CBLB502). Entolimod ™ (CBLB502) ist ein rekombinantes Protein, das ein breites Spektrum von protektiven Effekte auf die direkte Interaktion und Signalisierung über Toll-like Rezeptor 5 (TLR5), eine angeborene Immunsystem Rezeptor induziert. Es hat mehrere Vorteile gegenüber Agonisten von anderen TLRs, einschließlich derjenigen, die derzeit in der Entwicklung für onkologische Anwendungen, die sich aus seinen einzigartigen Wirkmechanismus.

Osiris Therapeutics

Osiris Therapeutics, Inc. ( OSIR ) ist ein führender Stammzellen Unternehmen auf die Entwicklung und Vermarktung von Produkten konzentriert, um medizinischen Bedingungen in den entzündlichen, autoimmune, orthopädischen und Herz-Kreislauf-Bereich zu behandeln. Osiris Stammzellprodukte erhebliche therapeutisches Potential aufgrund ihrer Fähigkeit, Entzündung zu regulieren, zu fördern Geweberegeneration und verhindern pathologischen Narbenbildung.

Ihre wichtigste Produkt in der Entwicklung gegen ARS, die von einem $ 225.000.000 Auftragsvergabe im Jahr 2008 erhielt unterstützt wird, ist Prochymal ™, eine Formulierung von adulten Stammzellen aus dem Knochenmark, die potenziell tödliche Komplikationen der akuten Strahlenkrankheit Syndrom (Behandlung von ARS ). Prochymal ™ ist ein hochgereinigtes Formulierung von mesenchymalen Stammzellen (MSCs), die in Kultur gezüchtet werden, erlaubt Großserienfertigung. Die MSCs in Prochymal ™ verwendet werden aus dem Knochenmark von gesunden erwachsenen Spendern isoliert. Da die Zellen erweitert werden kann, können Tausende von Dosen aus einer einmaligen Spende hergestellt werden.

Abschließender Hinweis

Derzeit gibt es keine FDA-zugelassenen Behandlungen für ARS. Im Bereich der Strahlung schützende Gegenmittel gibt es eine Reihe von Unternehmen in direktem Wettbewerb zueinander, aber wenn man bei diesen die Entwicklung von Therapien spezifisch für die GI-Komponente ARS schauen, verengt sich das Feld, um nur einige wichtige Akteure wie RxBio, Inc., der University of Arkansas Medical Sciences Center, und Soligenix. Und von diesen Unternehmen Soligenix mit seinen OrbeShield ™, meiner Meinung nach, scheint die vielversprechendste zu sein., Weil ihre Medikament ist bereits in der Regel durch die FDA zu verstehen, sicher zu sein, da die FDA hat bisher den Wirkstoff BDP genehmigt, OrbeShield ™. Nach ihrer jüngsten Vertrag Vorlage an BARDA (at BARDA Wunsch), ist das Unternehmen gut für die erste potenziell großen Auftrags, falls es bringen kann in das große Geld für die Zukunft, die sehr vorteilhaft für das Unternehmen und seine Investoren positioniert, zumal wo das Unternehmen die Marktkapitalisierung und Aktienkurs heute sind.

Mit einer Marktkapitalisierung von nur 20 Millionen Dollar, glaube ich Soligenix könnte eine interessante Investitionsmöglichkeit für die Zukunft sein. Angesichts der vielen ARS Auszeichnungen bisher von BARDA und DoD übergeben, und die Tatsache, dass BARDA Soligenix ersucht, einen Vorschlag für die Finanzierung unterbreiten, ich denke, die Chancen stehen gut, dass sie ein Multi-Millionen-Dollar-Vertrag Auszeichnung. Ferner kann das Unternehmen gegen seine Konkurrenz auf den folgenden differenzierenden Attribute OrbeShield ™ basiert konkurrieren:

• Generell weiter fortgeschritten als andere Programme gezielt GI ARS

* Oral-Tabletten machen Selbstverwaltung einfach für die Massen

• Umfangreiche Sicherheit der Menschen-Datenbank

• Fähigkeit zu formulieren und Herstellung im großen Maßstab und unter cGMP-Bedingungen

• Langfristige Drogen Stabilität, erfordert keine besonderen Lagerungsbedingungen (zB Kühlung)

• Vielversprechende präklinische Daten in einer großen Tiermodell

Risiken

Die Unternehmen in diesem Artikel erwähnt werden, sind den üblichen Risiken für Unternehmen in der Biotechnologie-Branche, einschließlich, aber nicht beschränkt auf, die Entwicklung von neuen technologischen Innovationen, Abhängigkeit von wichtigen Mitarbeitern, Schutz der proprietären Technologie, die Einhaltung der FDA-Vorschriften, Rechtsstreitigkeiten und Produkthaftung beschränkt .

:)

über 2 dollar?

in den letzten Tagen steigender Kurs und Volumen nimmt auch zu.
Die Produktpipeline ist der Hammer, nur 12 Mio. outstanding shares und derzeitige Marketcap von grade mal 20 Mio.$

seekingalpha.com/article/...ng-this-biotech?source=google_news

noch bevor

rauf gehts

bei den Aussichten...

ist bei Soligenix dick dabei mit über 3 Mio. Shares. Darüber hinaus kooperiert seine Firma Intrexon mit SNGX.

www.fiercebiotech.com/story/...ology-deals-intrexon/2013-05-01

www.finanznachrichten.de/...nt-of-orbeshield-in-gi-ars-008.htm

Marketcap bei etwa 33 Mio$ nach gestrigem Kurs. Barda zahlt bis zu 26 Mio, das schreit schon fast nach Neubewertung.

übers Uplisting an die AMEX oder Nasdaq gesprochen $$$$

auch hierzulande etwas Volumen reinkommt, ist schon schade als Alleinunterhalter bei sonem geilen Wert

"Securing a highly competitive BARDA contract provides important recognition as to the innovative quality and potential therapeutic impact of our technology," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix.  "This contract award provides the comprehensive funding necessary to continue development of OrbeShield™ while building upon the growing body of compelling scientific evidence supporting its use as a potential MCM for GI ARS.  We thank BARDA for their support and look forward to collaborating closely with them as we advance this technology."

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific MCMs against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield™

OrbeShield™ is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet releases BDP in the proximal portions of the GI tract and the other tablet releases BDP in the distal portions of the GI tract.  BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. To date, oral BDP has been safely administered to more than 350 human subjects in multiple clinical studies.  Oral BDP is also being developed in other GI disorders characterized by severe inflammation such as pediatric Crohn's disease, radiation enteritis and chronic Graft-versus-Host disease (cGVHD).

The FDA has cleared the Investigational New Drug (IND) application for OrbeShield™ for the mitigation of morbidity and mortality associated with GI ARS.  OrbeShield™ has also been granted Orphan Drug and Fast Track designations by the FDA for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

About BARDA

The Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, provides an integrated, systematic approach to the development and procurement of critical products needed for public health emergencies. In collaboration with the National Institutes of Health, Department of Homeland Security, and other federal agencies, BARDA plays a key role in the government's efforts to develop MCMs needed to prevent or mitigate potential health effects from exposure to chemical, biological, radiological and nuclear (CBRN) agents and other terrorist threats. Support for OrbeShield™ product development is being provided under a CBRN program to advance technologies and products to treat acute radiation syndrome (ARS).  Funding for BARDA's MCM development programs is authorized under the Pandemic and All Hazards Preparedness Act of 2006 (PAHPA) and reauthorized under the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). Additional MCM programs are funded by BARDA under the Project BioShield Act of 2004.

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™.  Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIAID.  Recently, Soligenix announced a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCE Soligenix, Inc.

seekingalpha.com/article/...to-come-for-soligenix?source=yahoo

finance.yahoo.com/news/...x-initiated-buy-maxim-120438967.html

die 2 dollar könnten nun endlich durch sein, gestern mit neuem allzeithoch auf tagesschluss ... Das wird spannend

"Securing this highly competitive NIH contract provides further recognition as to the innovative quality and potential therapeutic impact of our technology," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix.  "This contract award, in addition to the BARDA contract award recently received, has the potential to provide the necessary funding to advance the development of OrbeShield™ while building upon the scientific evidence supporting its use as a potential MCM for GI ARS.  We thank NIAID for their past and present support and look forward to collaborating closely with them as we advance this technology."

About GI ARS
ARS occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow the GI tract and later the lungs.   In the event of a nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed to >2 Gy are at high risk for development of clinically significant ARS. Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury which can result in death in 5-15 days.  The GI tract is highly sensitive due to the requirement for incessant proliferation of crypt stem cells and production of mucosal epithelium. The extent of injury to the bone marrow and the GI tract are the principal determinants of survival after exposure to TBI.  Although the hematopoietic syndrome can be rescued by bone marrow transplantation or growth factor administration, there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation. Therefore, there is an urgent need to develop specific MCMs against the lethal pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield™
OrbeShield™ is formulated for oral administration in GI ARS patients as a single product consisting of two tablets; one tablet releases BDP in the proximal portions of the GI tract and the other tablet releases BDP in the distal portions of the GI tract.  BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. To date, oral BDP has been safely administered to more than 350 human subjects in multiple clinical studies.  Oral BDP is also being developed in other GI disorders characterized by severe inflammation such as pediatric Crohn's disease, radiation enteritis and chronic Graft-versus-Host disease (cGVHD).

The FDA has cleared the Investigational New Drug (IND) application for OrbeShield™ for the mitigation of morbidity and mortality associated with GI ARS.  OrbeShield™ has also been granted Orphan Drug and Fast Track designations by the FDA for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.  In addition, OrbeShield™ was recently awarded a contract valued up to $26.3M by the US Department of Health and Human Service's Biomedical Advanced Research and Development Authority (BARDA).

About NIAID
The National Institute of Allergy and Infectious Diseases conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the US and around the world.

About Soligenix, Inc.
Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™.  Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3M and a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Recently, Soligenix announced a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

von Regierungsorganisationen innerhalb weniger Tage, das ist schon Hammer für sone kleine Biotechfirma.

einfach long gehen, wenn die großen etwas abhaben springt sie richtig

oder sie fängt besser gesagt erst an bei diesen glänzenden Aussichten.

This is the second government contract Soligenix secured within one week. Last week, Soligenix was awarded a $26.3 million contract by the US Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA). Both contracts are awarded for the advanced preclinical and manufacturing development of OrbeShield™ as a biodefense medical countermeasures (MCMs) for the treatment of gastrointestinal acute radiation syndrome (GI ARS).

The contracts are a huge win for Soligenix in our view. It not only provides non-dilutive funding for the development of the OrbeShield program for GI ARS, but more importantly validates the technology the company has developed over the years related to OrbeShield. Securing a highly competitive government contract provides important recognition as to the innovative quality and potential therapeutic impact of OrbeShield.

The total award will support the preclinical and manufacturing development activities necessary to successfully navigate and complete the FDA approval process for use of OrbeShield™ to treat GI ARS.

OrbeShield Advantages

OrbeShield™ is an oral immediate and delayed release BDP formulation that is being developed for the treatment of GI ARS (gastrointestinal acute radiation syndrome). OrbeShield in GI ARS has FDA Fast Track and Orphan Drug designations.

The GI tract is highly sensitive to ionizing radiation and the destruction of epithelial tissue is one of the first effects of radiation exposure. The rapid loss of epithelial cells leads to inflammation and infection that are often the primary cause of death in acute radiation injury. This is the same type of toxicity that occurs in Soligenix’s acute radiation enteritis clinical program with SGX201. As a result, there is a dual avenue of development for Soligenix, and OrbeShield™ is potentially a “dual use” compound, a desirable characteristic which is a specific priority of Biomedical Advanced Research and Development Authority (BARDA) for ARS and other medical countermeasure indications.

In preclinical studies, OrbeShield™ has demonstrated positive results in a canine GI ARS model which indicate that dogs treated with OrbeShield™ demonstrated statistically significant (p=0.04) improvement in survival with dosing at either 2 hours or 24 hours after exposure to lethal doses of total body irradiation (TBI) when compared to control dogs. The median survival was 100 days (p=0.04) when canines were treated 2 hours post exposure, 87 days (p=0.048) when canines were treated 24 hours post exposure. OrbeShield™ appears to significantly mitigate the damage to the GI epithelium caused by exposure to high doses of radiation.

Soligenix plans to conduct a follow-on replication dog study in 1H14 with results available also in 1H14. The FDA has cleared the IND application for OrbeShield™ for the mitigation of morbidity and mortality associated with GI ARS.

OrbeShield has other advantages beyond the efficacy seen in the canine model to date:


·         OrbeShield is an oral formulation, as opposed to injectable like many of the other biodefense vaccines and therapeutics; therefore, if a catastrophic event was to occur, the general population could dose themselves without the need for medical personnel to administer;

·         OrbeShield has demonstrated excellent safety profile in about 350 human subjects with the company’s oral BDP formulation;

·         cGMP Manufacturing process already at large commercial scale to produce sufficient quantities of OrbeShield, as needed.

Furthermore, Soligenix’s OrbeShield is being developed under specific FDA regulatory guidelines called the “Animal Rule.” The Animal Rule provides that under certain circumstances, where it is unethical or not feasible to conduct human efficacy studies, the FDA may grant marketing approval based on adequate and well-controlled animal studies when the results of those studies establish that the drug is reasonably likely to produce clinical benefit in humans. Demonstration of the product's safety in humans is still required.

We think the “Animal Rule” means a lot for Soligenix, because this can accelerate the development of OrbeShield and other vaccines. Once approved by the FDA, Soligenix will have the opportunity to negotiate a stock-pile contract with the US government.  These stock-pile or procurement contracts have been very lucrative for other companies supplying similar drugs to the US government.

A copy of the latest research report can be downloaded here >>  Soligenix Report

Please visit SCR.Zacks.com for additional information on our research and coverage universe, and Subscribe to receive our articles and reports emailed directly to you each morning.

da haben wohl einige die Möglichkeit genutzt nochmal nachzukaufen oder halt Gewinne mitzunehmen.

Wir bleiben aber weiter dabei und warten auf den nächsten Hammer, als da wären Rivax und Pedriatic Crohns Disease.

Soligenix Announces Initial $600,000 Investment and up to $10.6 Million Common Stock Purchase Agreement with Lincoln Park Capital Fund, LLC
PR Newswire
Soligenix, Inc. 1 hour ago

PRINCETON, N.J., Nov. 21, 2013 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it signed a stock purchase agreement with Lincoln Park Capital Fund, LLC (LPC) providing an initial investment in Soligenix of $600,000 and the availability of additional periodic investments up to $10.0 million over a 36 month term.

Upon execution of the agreement, the Company received an investment of $600,000 in exchange for the issuance of 285,714 shares of the Company's common stock to LPC.  The per share purchase price of $2.10 was equal to the closing price of the Common Stock on the day prior to the execution of the agreement.   At its sole discretion, Soligenix has the right to sell to LPC up to an additional $10.0 million of its common stock, in amounts as described in the agreement and subject to certain conditions, which include the effectiveness of a registration statement with the U.S. Securities and Exchange Commission covering the sale of the shares that may be issued to LPC. The purchase price of the shares will be based on prevailing market prices of Soligenix's shares immediately preceding the notice of a sale without any fixed discount.  Soligenix controls the timing and amount of any future investment and LPC is obligated to make such purchases, if and when the Company decides in accordance with the stock purchase agreement.  Additionally, there are no upper price limit restrictions, negative covenants or any restrictions on the Company's future financing activities. Soligenix can terminate the agreement at any time without any monetary cost or penalty.  LPC has also agreed not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company's shares of common stock.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "LPC has years of experience investing in life sciences companies, including technologies that address orphan indications, and we are pleased to have them as investors in the Company."  Dr. Schaber continued, "The ability to raise capital at or near market prices enhances our potential to pursue strategic alliances in a very efficient and opportunistic manner while staying committed to advancing our Phase 2 studies with SGX942 for the treatment of oral mucositis in head and neck cancer and SGX203 for the treatment of pediatric Crohn's disease."  

About Lincoln Park Capital

Lincoln Park Capital (LPC) is an institutional investor headquartered in Chicago, Illinois.   LPC's experienced professionals manage a portfolio of investments in public and private entities.  These investments are in a wide range of companies and industries emphasizing life sciences, specialty financing, energy and technology.  LPC's investments range from multiyear financial commitments to fund growth to special situation financings to long-term strategic capital offering companies certainty, flexibility and consistency.  For more information, visit www.lpcfunds.com

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™.  Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Recently, Soligenix announced a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

seekingalpha.com/article/...x-10-catalysts-to-look-for-in-2014

"As we are always looking for non-dilutive ways to fund our company, we are once again very pleased with NJEDA's decision to approve our application in this year's program," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "This NOL funding is a nice addition to other non-dilutive funding we have recently been awarded from BARDA and NIAID.  We are very thankful for New Jersey's continued support of its biotechnology industry."

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™.  Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

CONTACT: Joe Warusz, CPA, Acting Chief Financial Officer, (609) 538-8200, www.soligenix.com, Soligenix, Inc.
29 Emmons Drive, Suite C-10
Princeton, NJ 08540

von BARDA, NIAID und NJ Tax Programm in den letzten Monaten.
Marketcap bei 40 Mio, ein Witz hoch 10.

Vista Partners Initiates Coverage on Soligenix, Inc. (Ticker: SNGX); $5.50 Price Target
Marketwired
Vista Partners LLC March 18, 2014 9:00 AM

SAN FRANCISCO, CA--(Marketwired - Mar 18, 2014) - Vista Partners announced today that it has initiated coverage on Soligenix, Inc. (OTCBB: SNGX) with a twelve-month price target of $5.50. Soligenix, Inc. is a New Jersey based clinical stage biopharmaceutical company committed to developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases. Ross Silver, Principal Analyst at Vista Partners, stated, "Soligenix has signed an exclusive worldwide collaboration deal with Intrexon Corporation ($2.9B mkt cap) (NYSE: XON) to develop a novel passive immunotherapy for Melioidosis. Melioidosis, also known as Bp, is an often deadly infectious disease caused by the bacterium, Burkholderia pseudomallei, with some symptoms similar to those of the flu and pneumonia. Melioidosis occurs in many different places around the globe, currently however it is of greatest concern in southeast-Asia and northern Australia, where public officials see it as a major threat to the health of the population." Mr. Silver continues, "The Company also has an exclusive commercial collaboration with SciClone Pharmaceuticals ($250M mkt cap) (NASDAQ: SCLN) in China for SGX942 in the treatment of oral mucositis." Mr. Silver concludes, "The Company boasts a diverse pipeline with nine prospective drug candidates. The science behind the Company's prospective therapies has been and continues to be validated by a number of significant, important and influential entities such as government organizations and major pharmaceutical companies. To date the Company has been awarded approximately $40M mainly through BARDA, NIH and FDA grants/contracts. The Company has up to approximately $34 million in active government contract and grant funding still available to support its associated research programs through 2018."

To download a FREE copy of the Soligenix, Inc. research report, please visit www.vistapglobal.com and click the "download research" icon to gain access to the report.

About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm's professional staff has backgrounds in finance, corporate communications and investment banking. Vista focuses on investing globally across all market sectors. Vista also provides investment considerations on publicly traded companies through a platform of stock research reports, newsletters, company specific webpages and daily commentary. The platform of products is meant to serve as potential tools for investors to learn about investment considerations. It is Vista's mission to provide investors with tools that may enable them to make profitable investment decisions with the goal to deliver investment considerations that outperform small, mid and large cap equity indexes.

Please follow us on Twitter @VistaPResearch & Facebook at Vista-Partners to receive updates, thoughts and ideas about and our coverage universe of companies and more.

Disclaimer & Disclosure:
For a full list of disclaimers and disclosures, please visit our website www.vistapglobal.com or click here.
Contact:  

nach der langen Konsolidierung gehts endlich wieder rauf

"Securing this highly competitive NIAID contract provides further recognition as to the innovative quality and potential impact of both our vaccine and thermostabilization technologies," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  "With this new contract award, the Company now has up to $57 million in NIAID and BARDA funding to advance the biodefense business segment.  We thank NIAID for their past and present support and look forward to collaborating closely with them as we advance RiVax™ development towards potential FDA licensure and procurement for the national stockpile."

This is Soligenix's third awarded federal contract.  Soligenix's gastrointestinal acute radiation syndrome (GI ARS) program is supported by contract awards from both the Biomedical Advanced Research Development Authority (BARDA) and NIAID, totaling up to approximately $32 million to support the development of OrbeShield™ as a MCM for GI ARS.

About Ricin Toxin

Ricin toxin is a plant toxin thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. Ricin comes in many forms like powder, mist, or pellet. Ricin can also be dissolved in water and other liquids.  It is so powerful of a poison that the US Centers for Disease Control (CDC) estimate the lethal dose in humans is about the size of a grain of salt. Exposure to ricin results in local tissue necrosis and general organ failure leading to death within several days of exposure and is especially toxic when inhaled.  Ricin is a ribosome inactivating protein (RIP) and a potent member of the AB family of toxins.  Ricin inactivates the ribosomes in cells making them unable to produce proteins needed to survive and reproduce.  When ribosomes are inactivated, cells die.

There are currently no effective means to prevent the effects of ricin poisoning.  The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.  

About RiVax™

RiVax™ is Soligenix's proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin.  With RiVax™, Soligenix is a world leader in the area of ricin toxin vaccine research.

RiVax™ contains a genetically altered version of RTA chain containing two mutations that inactivate the toxicity of the ricin molecule.  A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant.  This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.  To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial.  Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™. In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer lasting antibodies than the adjuvant-free vaccine.

The development of RiVax™ has been sponsored through a series of grants from both NIAID and the US Food and Drug Administration (FDA), which were granted to Soligenix and to University of Texas Southwestern (UTSW) where the vaccine originated. To date, Soligenix and Dr. Ellen Vitetta and colleagues at UTSW have collectively received approximately $25 million in grant funding from NIAID for development of RiVax™ and related vaccine technologies. RiVax™ would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.

About ThermoVax™

ThermoVax™ is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines.  According to the Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain.  Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities.  Further, the World Health Organization (WHO) reports that 50% of all global vaccine doses are wasted because they are not kept within required temperature ranges.  NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production.  For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax™ has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency situations.

The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.  RiVax™ is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit).  By employing ThermoVax™ during their final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.

The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. The vaccine technology has been developed to date in collaboration with SRI International, the University of Kansas, the Wadsworth Center of the New York State Department of Health, and the Tulane National Primate Research Center under the sponsorship of the cooperative grant from NIAID.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201). Soligenix is also advancing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis and SGX301, its novel first-in-class photodynamic technology utilizing synthetic hypericin with safe visible light, for the treatment of cutaneous T-cell lymphoma.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure.  RiVax™ has demonstrated statistically significant preclinical survival results in a lethal aerosol exposure non-human primate model, and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers.  Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™.  Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million.  OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

To download a FREE copy of the Soligenix, Inc. research report, please visit www.vistapglobal.com and click the "download research" icon to gain access to the report.

About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm's professional staff has backgrounds in finance, corporate communications and investment banking. Vista focuses on investing globally across all market sectors. Vista also provides investment considerations on publicly traded companies through a platform of stock research reports, newsletters, company specific webpages and daily commentary. The platform of products is meant to serve as potential tools for investors to learn about investment considerations. It is Vista's mission to provide investors with tools that may enable them to make profitable investment decisions with the goal to deliver investment considerations that outperform small, mid and large cap equity indexes.

Please follow us on Twitter @VistaPResearch & Facebook at Vista-Partners to receive updates, thoughts and ideas about and our coverage universe of companies and more.

Disclaimer & Disclosure:
For a full list of disclaimers and disclosures, please visit our website www.vistapglobal.com or click here.

da ist noch mehr drin...

Soligenix (OTCQB:SNGX) is a late stage biopharmaceutical company focused on the development of therapeutics for the treatment of inflammatory diseases, cancer and biodefense applications. Their pipeline includes novel therapeutics for orphan diseases and vaccines/drugs for civilian and military biodefense purposes. The company's orphan disease program focuses on cutaneous T-cell lymphoma, pediatric Crohn's disease, oral mucositis, and acute radiation enteritis (Figure 1). Their biodefense pipeline includes vaccines for ricin and anthrax as well as drugs for gastrointestinal acute radiation syndrome and melioidosis (Figure 1).

Figure : Soligenix's clinical pipeline (www.soligenix.com/prod.shtml)

The company has recently announced several positive developments, including the acquisition of new technology, positive trial results and government contract funding exceeding $55 million. In this report, we highlight recent corporate events as we believe Soligenix is a low-risk investment with significant upside potential.

Therapeutics for Orphan and Rare Diseases

Acquisition of a Phase III Program for Cutaneous T-Cell Lymphoma (CTCL)

Soligenix acquired a novel orphan drug candidate, SGX301 (synthetic hypericin) on September 3, 2014 for the treatment of CTCL. SGX301, a Phase III drug candidate, was purchased from Hy Biopharma for up to $14 million dependent on successful achievement of certain development milestones. This purchase is predominantly (98%) in the form of restricted stock payments. CTCL is a type of non-Hodgkin's lymphoma (NHL) caused by a T-cell mutation in which there are no currently approved front-line treatments. It is estimated that CTCL affects over 20,000 individuals in the US with median survival of only 2.5 years in advanced disease.

SGX301, when combined with a safe light (fluorescent) source, can treat early-stage CTCL skin lesions. The photodynamic therapy allows for targeted application to skin lesions leaving adjacent normal tissues unaffected. Phase I and Phase II studies using SGX301 found the drug to be safe and well tolerated. In a Phase II, placebo-controlled study in patients with CTCL, the therapy yielded a response rate of 58.3% in CTCL patients compared to 8.3% in patients receiving placebo (p < 0.04, Figure 2). SGX301 has received orphan drug designation from the FDA for the treatment of CTCL.

Figure : www.soligenix.com/prod_reference_literat...

Based on these data, the company announced on September 17, 2014 that the FDA had agreed on a trial design to begin its pivotal Phase III clinical trial in the first half of 2015. The study will be a double-blind, randomized and placebo-controlled with the primary endpoint of evaluating CAILS (Composite Assessment of Index Lesion Severity) on the three worst CTCL lesions. The company expects top line data will be available in the second half of 2016. We estimate SGX301 could be approved by the FDA in 2017 if data from the Phase III trial are positive.

In addition to CTCL, SGX301 may also be used for other indications such as psoriasis. Psoriasis afflicts over 7 million people a year in the United States alone, thus this indication could further expand the company's pipeline. Other forms of photodynamic therapy are frequently used for the initial treatment of psoriasis; however, these therapies pose an increased risk of melanoma and non-melanoma skin cancers. SGX301 could provide a safe and more effective treatment for these patients. We believe that the acquisition of this late-stage candidate is a de-risking event for the company.

Grant Award to Support a Phase II Clinical Trial for Oral Mucositis

In December 2013, Soligenix initiated a Phase II clinical trial using its drug candidate, SGX942, for the treatment of oral mucositis in patients with cancer of the mouth and oropharynx. SGX942 is a novel synthetic peptide that has been shown to reduce tissue damage as a result of chemotherapy and/or radiotherapy in vivo. Patients often experience debilitating oral mucositis as a result of the adverse side effects of treatment with radiation and chemotherapy. In April 2014, the National Institute of Dental and Craniofacial Research awarded Soligenix a Small Business Innovation Research (SBIR) grant to further support the trial evaluating SGX942.

The primary endpoint of this trial will be assessed on the basis of incidence and duration of oral mucositis throughout the course of radiation treatment. Secondary endpoints will assess patient reported outcomes and pharmacoeconomic parameters such as hospitalization and radiation-associated side effects, including mouth stiffness (trismus) and dryness (xerostomia). The company conducted a Phase I clinical trial of SGX942 which showed the drug to be safe and well tolerated in 84 healthy volunteers. Results from the Phase II trial are expected in the first half of 2015.

Vaccines for Biodefense Applications

$24.7 Million Award for Heat Stable Ricin Vaccine from the National Institute of Allergy and Infectious Diseases (NIAID)

Soligenix's ricin vaccine development program has received two positive developments in the recent months. Currently, no approved vaccines exist to combat the detrimental effects of ricin poisoning. The company is developing a heat stable version of its ricin vaccine called RiVax, which enables stock piling of the vaccine to be deployed in the event of a terrorist act. In September, positive results of a preclinical study in non-human primates resulted in complete protection from exposure of 3-5 times the known lethal dose of ricin. The study yielded statistically significant survival data (p < 0.002) with treated primates exhibiting neutralizing antibodies in the blood. Typically, animals succumb to the ricin toxin within 36 hours of exposure and develop severe lung damage. These data represent a significant leap forward in establishing efficacy under the FDA's "animal rule". Under this rule, vaccines cannot be tested in humans unless safety and efficacy are first established in non-human primates.

Subsequently, the company received a government contract for up to $24.7 million from the NIAID to develop the product for counter terrorism measures. If subsequent studies are successful, RiVax could be added to the US Strategic National Stockpile and potentially dispensed if ricin is used as a biological weapon in a terrorist attack. The positive primate data and the large financial award from the NIAID help validate the technology. The company plans to execute human safety and immunogenicity trials along with advancing the manufacturing and scale up of RiVax.

Rapidly Acting Heat Stable Anthrax Vaccine

In addition to ricin, Soligenix is also developing a heat stable anthrax vaccine. The vaccine called VeloThrax combines a toll-like receptor 4 (TLR4) agonist as a secondary adjuvant in order to activate the immune system to help the body recognize foreign pathogens. Using a TLR4 agonist, the company believes that the body will be able to more quickly become protected after vaccine administration. In August, the company showed that animal models using the vaccine suggest complete immunity against anthrax can be achieved after only two administrations of the vaccine. This observation is quite compelling, as current vaccines without the TLR4 adjuvant require up to five vaccinations over 18 months in order to become protected against the pathogen. The vaccine is also stable at high temperatures for a least three months meaning that it was capable of inducing antibodies against anthrax for extended durations of time. We believe VeloThrax provides a distinct advantage over other anthrax vaccines by requiring fewer vaccinations as well as being stable at high temperatures for long periods. The company plans to develop VeloThrax under the support of government grants and contracts. If development is successful, there is the potential for the company to be awarded significant procurement contracts from the government, which could exceed $500 million.

Combination of RiVax and VeloThrax for Protection against Ricin and Anthrax

Soligenix is also testing the combination of both RiVax and VeloThrax to be administered as a single vaccine. Preclinical data thus far has shown that both vaccines administered in a single dose can induce antibodies against both pathogens. Furthermore, these antibodies were present 200 days after immunization after only two vaccinations. These studies were sponsored under a $9.4 million cooperative grant from the NIAID. Results suggest that long-term immunity upon simultaneous vaccination can be achieved. This is important because both vaccines are developed for military usage and emergency first responders.

Soligenix is Expanding its Clinical Pipeline
Pediatric Children's Crohn's Disease

The company is currently developing SGX203, an anti-inflammatory agent, for the treatment of pediatric Crohn's disease. Currently, there is no viable first-line treatment for pediatric Crohn's disease and current therapies such as Remicade carry a black box warning about its potential to induce malignancies. SGX203 is designed to block resultant inflammation caused by Crohn's disease in the GI tract. In a Phase I study completed in May 2013, pharmacokinetic (PK) profiling established a safe and well tolerated dosing regimen. Soligenix plans to initiate a Phase II/III trial of SGX203 for the treatment of pediatric Crohn's disease in the first half of 2015 with primary endpoint data expected in the second half of 2016. The drug has received both Fast Track and Orphan Drug designations from the FDA and we believe SGX203 has the potential to meet an important medical need in children with this serious illness.
Prevention of Acute Radiation Enteritis

In the US, more than 100,000 patients per year are subject to radiation for the treatment of cancer and many of these patients develop acute radiation enteritis. The disease results in inflammation of the lining of the bowels and patients are burdened by vomiting, abdominal pain, bleeding and can require additional hospitalization. Soligenix is developing SGX201, an orally formulated anti-inflammatory drug, designed to block inflammation in the GI tract in patients receiving radiotherapy for the treatment of lower GI cancers. The company has completed a Phase I/II trial and determined the drug was safe and well tolerated. This Fast Track designated drug is poised to enter a Phase II trial in 2015, contingent upon continued government funding, with primary endpoint data expected in the second half of 2016. There are no approved therapies for this indication, thus a positive trial using SGX201 will open up yet another market for Soligenix.

Strategic Cash Management Combined with Non-dilutive Financing

The company is well funded as it signed a stock purchase agreement with Lincoln Park Capital Fund in November 2013 allowing for the availability of periodic investments of up to $10 million over 36 months through the sale of its common stock. As of the end of June 2014, the company had approximately $5.0 million in cash on hand and management has remained aggressive in the pursuit of government grants and contracts across its pipeline. It has already secured more than $55 million in grants and contracts, as these are great non-dilutive financing to support its pipeline. Thus, Soligenix can focus on advancing its clinical programs and its robust pipeline (Figure 3) without the fear of any near term dilution.

(click to enlarge)

Figure : www.soligenix.com/prod_reference_literat...

In addition to the funding already previously mentioned, Soligenix was recently awarded an additional $2.1 million in August to advance the preclinical development of OrbeShield. OrbeShield is a drug that is designed to protect against the exposure to ionizing radiation after a natural disaster. The total contract award is valued at up to $6.4 million over three years. This program is being supported by awards from the Biomedical Advanced Research Development Authority and NIAID for up to $32 million.

Soligenix Shares Are Significantly Undervalued

Soligenix has developed a diversified drug pipeline in therapeutics, biodefense vaccines and vaccine heat stabilization technology. Results for SGX942 in Oral Mucositis should be available in the first half of 2015. Positive data from this Phase II study will validate the company's platform and significantly de-risk its technology as the market for this disease is quite large. This drug also has many other potential targets in infectious diseases and GI disorders thus further expanding the company's potential market share.

Additionally, Soligenix's vaccines and biodefense program have the potential to provide significant value to the company. If approved by the FDA, the company will most likely establish contracts to stockpile its vaccines with US and foreign governments. Traditionally, stockpile or procurement contracts have been very lucrative from the government. Since their vaccines fill a major unmet need for protection against potential bioterrorism events, they should provide significant cash flow to the company.

Currently, shares of Soligenix are trading at around $1.75 per share, which values the company at a $38 million market cap. At current levels, we believe shares are significantly undervalued. Thus, we maintain an outperform rating and a 12-month price target of $4.50 per share. Similar biotechnology companies at this development stage are valued between $50 million to $1 billion. Soligenix is a late stage company with multiple Phase II and III programs and two more programs moving into Phase II/III in 2015. There will be multiple catalysts (Figure 3) in the next 6 to 18 months with the vaccine program unprecedented compared to its peers; therefore, this company may be a low risk, high reward opportunity.

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Research and development expenses were $5.1 million as compared to $1.2 million and $7.3 million as compared to $4.1 million for the quarter and nine months ended September 30, 2014 and 2013, respectively.  For the quarter ended September 30, 2014, the increase of $3.9 million is attributable to the acquisition of SGX301, synthetic hypericin, from Hy BioPharma paid in the form of $0.25 million in cash and $3.75 million in restricted common stock.  For the nine months ended September 30, 2014, the increase of $3.2 million is attributable to the acquisition of SGX301 offset by a $1.5 million non-cash charge which was included in the 2013 nine months expenses relating to our collaboration with Intrexon Corporation (Intrexon).

General and administrative expenses were $0.7 million as compared to $0.7 million and $2.4 million as compared to $1.9 million for the quarter and nine months ended September 30, 2014 and 2013, respectively.

Operating expenses increased by $3.9 million and $3.7 million for the quarter and nine months ended September 30, 2014, respectively. The increase in operating expenses for the quarter ended September 30, 2014 is primarily related to the acquisition of SGX301, synthetic hypericin, and for nine months ended September 30, 2014 primarily related to the acquisition of SGX301, synthetic hypericin, offset by a $1.5 million non-cash charge in 2013 nine months expenses related to our collaboration with Intrexon.

For the three and nine months ended September 30, 2014, other net income/(expense) included a $0.8 million and $(0.2) million change in fair value of the warrant liability related to warrants issued in connection with the Company's June 2013 registered public offering.

As of September 30, 2014, the Company's cash position was $4.2 million.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "During this quarter we made significant progress in both our business segments. In our BioTherapeutics segment we expanded our pipeline with the acquisition of SGX301, synthetic hypericin, with plans to initiate a pivotal Phase 3 clinical trial in the first half of 2015.  We are also continuing to actively enroll patients in our Phase 2 study with SGX942 in the treatment of oral mucositis in head and neck cancer.  In our Vaccine/BioDefense segment, our RiVax™ program utilizing our ThermoVax™ platform was further validated with the award of a multi-year NIAID contract valued up to $24.7 million.  This contract award coupled with our contracts awarded for OrbeShield™ in GI ARS of up to $32.7 provides  up to  $57 million in non dilutive program funding.  As we further expanded our development pipeline, while continuing to advance our current clinical programs, we continue to effectively manage cash burn ending the quarter with $4.2 million in cash.  I look forward to providing updates for the balance of 2014 and throughout 2015."    

Soligenix Recent Highlights:

   On September 23, 2014, the Company announced that it had appointed Rasappa Arumugham, PhD, as its Vice President of Biopharmaceutical Development. Dr. Arumugham has over 25 years of diverse experience in biopharmaceutical research and development (R&D) in the areas of formulation research, analytical method development, quality control (QC), and manufacturing. He has a proven track record in development, scale-up, and technology transfer supporting commercialization of vaccines and biologics, including Prevnar®, Tetramune™, HibTITER®, Meningitec® Conjugate and meningitis B (bivalent rLP2086) Lipoprotein Subunit Vaccines.
   On September 19, 2014, the Company announced that it was awarded a contract valued at up to $24.7 million inclusive of options by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID). The objectives of the contract are to advance the development of Soligenix's thermostabilization technology, ThermoVax™, combined with the company's ricin toxin vaccine, Rivax™, as a medical countermeasure to prevent the effects of ricin exposure.
   On September 17, 2014, the Company announced that an agreement had been reached with the US Food and Drug Administration (FDA) on the design of a pivotal, Phase 3 clinical trial evaluating SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).
   On September 9, 2014, the Company announced that the US Patent and Trademark Office (US PTO) granted patent 8,808,710 entitled "Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition." The newly issued patent claims cover compositions and methods for manufacturing vaccines utilizing ThermoVax™, the Company's proprietary vaccine thermostabilization technology. The new patent complements US patent 8,444,991, granted on May 21, 2013, that primarily included claims for methods of making stabilized vaccines.
   On September 5, 2014, the Company announced the acquisition of a novel orphan drug candidate, known as SGX301 (synthetic hypericin). SGX301 is poised to enter pivotal Phase 3 clinical testing for the treatment of CTCL and is highly synergistic with the company's existing development pipeline. As part of the acquisition, Soligenix acquired all rights for synthetic hypericin, including intellectual property, and preclinical and clinical data. SGX301 is a novel, first-in-class, photodynamic therapy utilizing safe visible light for activation. The active ingredient, synthetic hypericin, is a potent photosensitizer which is topically applied to skin lesions and activated by fluorescent light.
   On September 2, 2014, the Company announced promising preliminary results from a preclinical study with its ricin toxin vaccine RiVax™, in a non-human primate (NHP) lethal aerosol exposure model. The study demonstrated that NHPs vaccinated with RiVax™ were completely protected against a lethal aerosol of ricin toxin with a highly significant survival benefit (p

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201). Soligenix is also advancing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis and SGX301, its novel first-in-class photodynamic technology utilizing synthetic hypericin with safe visible light, for the treatment of cutaneous T-cell lymphoma.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure.  RiVax™ has demonstrated statistically significant preclinical survival results in a lethal aerosol exposure non-human primate model, and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers.  Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™.  Recently, Soligenix was awarded a NIAID contract valued up to $24.7 million to further advance the development of its heat stable RiVax™ as a medical countermeasure to prevent the effects of ricin exposure. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million.  OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

"I enthusiastically support Soligenix in their efforts to improve outcomes for patients with CTCL, affecting up to 50,000 patients in the US," stated Alain Rook, MD, Director, Cutaneous Lymphoma Program, Perelman School of Medicine of the University of Pennsylvania. "I have had a lengthy scientific and clinical interest in hypericin and am pleased that the Soligenix team is advancing this product.  I believe that SGX301 has the potential to be a major step forward in the treatment of CTCL by providing a safer alternative therapy in comparison to other forms of phototherapy over the course of the patients' disease than is currently available.  I look forward to working with my esteemed colleagues to support Soligenix in advancing this important development program forward."

"We are pleased to be able to attract such esteemed and enthusiastic professionals to participate as members of our Medical Advisory Board," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The initiation of a CTCL program marks the first step in the development of our newly acquired SGX301 program.  We look forward to working with the MAB and initiating the pivotal clinical trial in 2015."

The MAB Members

Alain Rook, MD

Dr. Rook is a Professor of Dermatology at the Perelman School of Medicine at the University of Pennsylvania and is the Director of the CTCL and Extracorporeal Photopheresis Program. He has conducted seminal studies on the photodynamic therapeutic efficacy of synthetic hypericin in CTCL and psoriasis patients and on its apoptotic activity in malignant cancer cells. Dr. Rook's research has been supported by the Leukemia and Lymphoma Society, the National Institutes of Health and National Cancer Institute. He graduated from the University of Michigan with an MD degree.  Dr. Rook is Board Certified in Dermatology, Internal Medicine, and Nephrology.

Youn Kim, MD

Dr. Kim is the Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma at Stanford University. She is an international renowned expert in cutaneous lymphomas and is the director of the Multi-disciplinary Cutaneous Lymphoma Program and Medical Director of the photopheresis Unit at Stanford Medical Center and is Co-Director of the Lymphoma Research Program at the Stanford Cancer Institute. She graduated from Stanford University School of Medicine with an MD degree. Dr. Kim is Board Certified in Dermatology.

Gary Wood, MD

Dr. Wood is the Chair and Professor of Dermatology at the University of Wisconsin. He is an internationally recognized expert in cutaneous lymphomas.  Dr. Wood has served as President of the International Society for Cutaneous Lymphomas. He has authored more than 350 articles, chapters and abstracts, mostly focused on cutaneous oncology. He also directs the Immunodiagnosis Lab that offers comprehensive diagnostic testing for skin diseases. Dr Wood graduated from the University of Illinois at Chicago with an MD degree. Dr. Wood is triple board certified in dermatology, dermatopathology and anatomic pathology.

Madeleine Duvic, MD

Dr. Duvic is a Professor of Internal Medicine and Dermatology, and serves as the Deputy Chairman of the Department of Dermatology at The University of Texas, MD Anderson Cancer Center. She is a founding member of the US Cutaneous Lymphoma Consortium, former board member of the American Academy of Dermatology and recent vice president of the Society for Investigative Dermatology. She has been Principal Investigator of numerous clinical trials and translational research studies of T-cell mediated diseases and malignancies, especially CTCL. With over 400 scientific publications, her work is focused on developing and improving therapy for CTCL. Dr. Duvic graduated from Duke University Medical School with a MD degree and completed an internship and residencies in internal medicine and dermatology, served as chief resident, and completed fellowships in molecular biology and geriatrics. Dr. Duvic is Board Certified in Internal Medicine and Dermatology and heads the CTCL multi-disciplinary clinic at MD Anderson Cancer Center.

About CTCL

Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.  Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.  These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.

About SGX301

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later.  Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.  In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective:  58.3% compared to 8.3%, respectively.   SGX301 has received orphan drug designation from the US Food and Drug Administration.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.

Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs is supported by our heat stabilization technology, known as ThermoVax™, under existing and on-going government contract funding.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.  

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Preclinical studies for both SGX943 and RiVax™ were supported by grant awards from the National Institute of Allergy and Infectious Diseases (NIAID).

Oral Presentation:

   Innate Defense Regulators as a Treatment for Melioidosis presented by Dr. Oreola Donini, Chief Scientific Officer, Soligenix, Inc., on February 10, 2015 from 5:45-6:00 PM EST. The abstract is available at:
   www.abstractsonline.com/Plan/...f-5fd3-4ea2-bbe7-ca4cd9aa0577.

Poster Presentation:

   Thermostable Subunit Vaccine Results in Protective Immunity in Rhesus Macaques in an Inhalational Ricin Model attended by Dr. Oreola Donini, Chief Scientific Officer, Soligenix, Inc., on February 11, 2015 from 3:45-5:15 PM EST. The abstract is available at: www.abstractsonline.com/Plan/...6f-5fd3-4ea2-bbe7-ca4cd9aa0577

About ASM Biodefense and Emerging Diseases Research Meeting

The ASM Biodefense and Emerging Diseases Research Meeting is a forum for discussion between individuals conducting research to defend against bioterrorism and decision makers funding and shaping the future research agenda. Emerging infectious diseases serve as a framework for understanding the public threat of bioterrorism.  

For more information about the 2015 ASM Biodefense and Emerging Diseases Research meeting, please refer to the conference website at asmbiodefense.org/index.php/meeting/2015-biodefense-meeting.

About Melioidosis

Melioidosis is a potentially fatal infection caused by the Gram-negative bacillus, Burkholderia pseudomallei (Bps). Highly resistant to many antibiotics, Bps can cause an acute disease characterized by a fulminant pneumonia and a chronic condition that can recrudesce. There is no preventive vaccine or effective immunotherapy for melioidosis. Therefore, there is a significant medical need for improved prevention and therapy.

Bps and the closely-related Burkholderia mallei (Bm) are considered possible biological warfare agents by the Department of Health and Human Services (DHHS) because of the potential for widespread dissemination through aerosol. Bps is classified as a Tier 1 biothreat and a category B priority pathogen by the NIAID and is a top 5 priority in the most recent Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Strategy document.

Bps infection (melioidosis) is a major public health concern in the endemic regions of Southeast Asia and Northern Australia. Moreover, the organism has a worldwide distribution and the full extent of global spread is likely underestimated. Bps activity is seen in Southeast Asia, South America, Africa, the Middle East, India, and Northern Australia. The highest pockets of disease activity occur in Northern Australia and Northeast Thailand, Burma and Vietnam, and is likely under-reported in China. In Northeast Thailand, the mortality rate associated with Bps infection is over 40%, making it the third most common cause of death from infectious disease in that region after HIV/AIDS and tuberculosis.

About SGX943

SGX943 is the drug product designation for the active ingredient SGX94 in the treatment of melioidosis. SGX94 is an IDR, a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation-therapy. SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections. SGX94 and related analogs have a strong intellectual property position, including composition of matter. SGX94 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development to date, inclusive of government grants. SGX94, the active ingredient in SGX942, is also in clinical development for the treatment of oral mucositis.

The testing of SGX943 in melioidosis is currently being supported by a NIAID Small Business Innovation Research (SBIR) grant valued at approximately $300,000 over one year.

About Ricin Toxin

Ricin toxin is a plant toxin thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. Ricin comes in many forms like powder, mist, pill, or pellet. Ricin can also be dissolved in water and other liquids. As a poison, ricin is so potent that the US Centers for Disease Control (CDC) estimates the lethal dose in humans is about the size of a grain of salt. Exposure to ricin results in local tissue necrosis and general organ failure leading to death within several days of exposure, and is especially toxic when inhaled.  Ricin is a ribosome inactivating protein (RIP) and a potent member of the AB family of toxins. The enzymatic ricin toxin A subunit (RTA) is an RNA-N-glycosidase which cleaves a specific adenine residue with eukaryotic 28S ribosomal RNA, leading to protein synthesis arrest and cell death.

There are currently no effective means to prevent the effects of ricin poisoning. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.

About RiVax™

RiVax™ is Soligenix's proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin. With RiVax™, Soligenix is a world leader in the area of ricin toxin vaccine research.

RiVax™ contains a genetically altered version of RTA chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals. To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial. Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants.  The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™. In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer lasting antibodies than the adjuvant-free vaccine.

The development of RiVax™ has been sponsored through a series of grants from both NIAID and the US Food and Drug Administration (FDA), which were awarded to Soligenix and to University of Texas Southwestern (UTSW) where the vaccine originated. To date, Soligenix and Dr. Ellen Vitetta and colleagues at UTSW have collectively received approximately $25 million in grant funding from the US government for development of RiVax™ and related vaccine technologies. RiVax™ would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack. RiVax™ is currently the subject of a contract valued at up to $24.7 million inclusive of options over a period of 6 years and awarded by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by NIAID).

About ThermoVax™

ThermoVax™ is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines. According to the Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain. Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities.  Further, the World Health Organization (WHO) reports that 50% of all global vaccine doses are wasted because they are not kept within required temperature ranges. NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production. For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax™ has the potential to facilitate easier storage and distribution of Strategic National Stockpile vaccines in emergency situations.

The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. RiVax™ is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit). By employing ThermoVax™ during their final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.

The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. The vaccine technology has been developed to date in collaboration with SRI International, the University of Kansas, the Wadsworth Center of the New York State Department of Health, and the Tulane National Primate Research Center under the sponsorship of the cooperative grant from NIAID.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.

Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation XON, +2.68% focused on the joint development of SGX101 for the treatment for melioidosis.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

To view the original version on PR Newswire, visit:www.prnewswire.com/news-releases/...shington-dc-300028851.html

SOURCE Soligenix, Inc.

Copyright (C) 2015 PR Newswire. All rights reserved
Stock References

   XON
   +0.80 +2.68%

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SAN FRANCISCO, CA--(Marketwired - Feb 12, 2015) - Vista Partners announced today that it has updated coverage on Soligenix, Inc. ("The Company" or "SNGX") (OTCQB: SNGX), a clinical stage biopharmaceutical company based in Princeton, New Jersey, and maintains its twelve-month price target of $7.00. Ross Silver, Principal Analyst at Vista Partners, stated, "The Company boasts a diverse pipeline with ten prospective drug candidates, including a Phase 3 ready asset slated to enter the clinic in early 2015 and Phase 2 data due on SGX942, the Company's clinical candidate for the treatment of Oral Mucositis, due by the end of June 2015. Mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy." Mr. Silver goes on to state, "The science behind the Company's prospective therapies has been and continues to be validated by a number of significant, important and influential entities such as government organizations and major pharmaceutical companies. The Company has been awarded numerous government grants and entered into strategic agreements with two companies Intrexon (~$3.5B mkt cap.) and SciClone (~$390M mkt cap)." Mr. Silver concludes, "The Company has up to approximately $57 million in active government contracts and grant funding still available to support its associated research programs through 2018."

To download a FREE copy of the Soligenix, Inc. research report, please visit www.vistapglobal.com and click the "download research" icon to gain access to the report.

About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm's professional staff has backgrounds in finance, corporate communications and investment banking. Vista focuses on investing globally across all market sectors. Vista also provides investment considerations on publicly traded companies through a platform of stock research reports, newsletters, company specific webpages and daily commentary. The platform of products is meant to serve as potential tools for investors to learn about investment considerations. It is Vista's mission to provide investors with tools that may enable them to make profitable investment decisions with the goal to deliver investment considerations that outperform small, mid and large cap equity indexes.

Please follow us on Twitter @VistaPResearch & Facebook at Vista-Partners to receive updates, thoughts and ideas about and our coverage universe of companies and more.

Disclaimer & Disclosure:
For a full list of disclaimers and disclosures, please visit our website www.vistapglobal.com or click here.  

über 800.000 Stück heute gehandelt. Soligenix hat nur ca. 25 Mio. Aktien am Markt.

fast kein Interesse besteht. Sngx hat gut cash, Förderung staatl. Organisationen in mio Höhe, Medikament in Phase 3, eine Riese Pipeline, jv mit intrexon der Firma von biotech mogul Kirk uvm.

Marketcap von ca. 25 mio. Bei den geringen float besteht hier die nächsten Wochen und Monate explosionspotential

In the study, 12 animals were vaccinated with RiVax™ and 6 animals were given an injection of placebo (unvaccinated control).  Each animal received 3 intramuscular injections, administered at time 0, 30 days and 60 days.  Vaccination with RiVax™ was well tolerated with no evidence of elevated heart rate, respiration or temperature.  All RiVax™-vaccinated animals generated neutralizing antibodies after the third injection.  To fully test the efficacy of the vaccine,  all animals were exposed to an aerosol of ricin toxin 3-5 times the amount that is known to result in death of untreated animals.  All RiVax™-vaccinated animals survived exposure, while all unvaccinated control animals died within 40 hours, demonstrating a statistically significant (p<0.0001) improvement in survival.  Moreover, the lungs of the RiVax™-vaccinated animals did not demonstrate any signs of irreversible damage, unlike those of the unvaccinated control animals.

"The improvement in both survival and morbidity with the use of this well-tolerated vaccine is a significant step forward in the development of RiVax™ for emergency preparedness use", stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. "Previous studies with RiVax™ have demonstrated significantly enhanced thermostability indicating that cold chain storage will potentially not be required for this vaccine, enabling it to be stored and distributed at room temperature.  RiVax™ is currently the subject of a preclinical and clinical development contract awarded by the National Institute of Allergy and Infectious Diseases (NIAID) and worth up to $24.7 million over 6 years."

About Ricin Toxin

Ricin toxin is a plant toxin thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. Ricin comes in many forms like powder, mist, pill, or pellet.  Ricin can also be dissolved in water and other liquids.  As a poison, ricin is so potent that the US Centers for Disease Control (CDC) estimates the lethal dose in humans is about the size of a grain of salt.  Exposure to ricin results in local tissue necrosis and general organ failure leading to death within several days of exposure, and is especially toxic when inhaled.  Ricin is a ribosome inactivating protein (RIP) and a potent member of the AB family of toxins.  The enzymatic ricin toxin A subunit (RTA) is an RNA-N-glycosidase which cleaves a specific adenine residue with eukaryotic 28S ribosomal RNA, leading to protein synthesis arrest and cell death.

There are currently no effective means to prevent the effects of ricin poisoning.  The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.

About RiVax™

RiVax™ is our proprietary vaccine candidate being developed to protect against exposure to ricin toxin, and if approved would be the first ricin vaccine. RiVax™ has demonstrated statistically significant (p < 0.0001) preclinical survival results in a lethal aerosol exposure non-human primate model, and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant.  This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of  RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.  To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial.  Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™.  In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer lasting antibodies than the adjuvant-free vaccine.

The development of RiVax™ has been sponsored through a series of grants from both NIAID and the US Food and Drug Administration (FDA), which were awarded to Soligenix and to Dr. Ellen Vitetta and colleagues at the University of Texas Southwestern (UTSW) where the vaccine originated. Most recently, Soligenix was awarded a contract valued at up to $24.7 million by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID) to advance the development of Soligenix's thermostabilization technology, ThermoVax™, combined with the company's ricin toxin vaccine, Rivax™ as a medical countermeasure (MCM) to prevent the effects of ricin exposure.

RiVax™ has been granted orphan drug designation by the FDA for the prevention of ricin intoxication.

About ThermoVax™

ThermoVax™ is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines.  Cold chain requirements add considerable cost to the production and storage of current conventional vaccines.  According to the Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain.  Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities.  Further, the World Health Organization (WHO) reports that as much as 50% of all global vaccine doses are wasted because they are not kept within required temperature ranges.  NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production.  For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax™ has the potential to facilitate easier storage and distribution of Strategic National Stockpile vaccines in emergency situations.

The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.  RiVax™ is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit).  By employing ThermoVax™ during their final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.

The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. The vaccine technology has been developed to date in collaboration with SRI International, the University of Kansas, the Wadsworth Center of the New York State Department of Health, and the Tulane National Primate Research Center under the sponsorship of the cooperative grant from NIAID.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.

Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™.  Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation XON, +2.75% focused on the joint development of SGX101 for the treatment for melioidosis.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.





To view the original version on PR Newswire, visit:www.prnewswire.com/news-releases/...shington-dc-300033001.html

SOURCE Soligenix, Inc.

Copyright (C) 2015 PR Newswire. All rights reserved
Stock References

   XON
   +1.05 +2.75%

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zum W:0 Board, da ist deutlich mehr los als hier.
www.wallstreet-online.de/diskussion/...opharma#neuster_beitrag

It seems that investors are reconsidering the initial negative reaction from last year and are now showing considerable support for the company. It is true that SNGX has a lot to offer when compared to a significant portion of the other pharmaceutical pennystocks. The financial report for the quarter ending September 30, 2014, showed that back then the company had:

• $4.2 million cash
• $5.7 million total current assets
• $10.5 million total current liabilities
• $2.7 million revenue
• $4.3 million net loss

The amount of the reported liabilities is alarming but it should be noted that $7.4 million of them consist of warrant liability.

With the money acquired through the public offering SNGX plans to fund the Phase III clinical study of its SGX301 drug for the treatment of cutaneous T-cell lymphoma. The study is scheduled to begin in the first half of 2015. At the same time the SGX942 drug is currently in Phase II clinical trial with data expected to be presented by the end of the next quarter.

SNGX has also received around $57 million in government contracts for the development of their vaccine candidates. Last Friday the company announced positive results from the preclinical study of their heat-stabilized ricin toxin vaccine (RiVax). The Rivax is the subject of a contract worth up to $24.7 million over the period of 6 years awarded to the company by the National Institute of Allergy and Infectious Diseases (NIAID).

Despite its appeal investors must not forget that the risks around SNGX remain significant. The company is still far away from having a product approved for commercialization and it may need more external financing in order to move forward with its planned clinical trials. That is why any position in the stock should be attempted only after doing extensive research and careful planning.

mit Milliardär Randal Kirk als Investor

For Kirk, who already made a fortune from New River and Clinical Data and has – by virtue of his 100 million shares in the newly IPO’d market darling -- just made another one, it is only the latest episode in a storied and glittering career. Truly the industry legend knows a good bet when he sees one, making his interest in Soligenix (OTCBB:SNGX) all the more heartening for the New Jersey-based development stage biopharmaceutical company.

The company, which has already seen its stock rise almost 150 per cent in the calendar year so far, caught the renowned life sciences billionaire’s eye earlier this year with its development of a treatment for high priority government biothreat melioidosis, a contagion which has the potential for widespread dissemination through aerosol. The infectious disease is caused by a bacterium that is highly resistant to antibiotic regimens, with mortality rates as high as 40 per cent in parts of Southeast Asia. In May, the company signed an exclusive worldwide collaboration agreement with Intrexon, today’s market livening IPO subject, for the development of a treatment for the disease.

Soligenix itself just closed financing worth a little over $7.1 million in a public offering of common stock and warrants in order to advance its candidates; in that instance too, the renowned billionaire life sciences investor had a role to play, in that a chunk of the funds originated with a firm linked to Kirk himself.

Soligenix has numerous drug candidates under its belt including multiple programs targeting indications that each have at least $200 million plus of worldwide market potential.

von 0,8€ auf 1,45€ seit anfang des jahres.

This Phase 2 study is a randomized, double-blind, dose-ranging, placebo-controlled trial, initially set to enroll approximately 75 subjects across 3 SGX942 dose groups and placebo, focused on demonstrating the safety and biologic activity of SGX942 in patients with tumors of the mouth and oropharynx who often experience debilitating oral mucositis as a consequence of tumor treatment with CRT.  The primary efficacy assessment is the comparison of the incidence and/or duration of both ulcerative and severe oral mucositis throughout the subjects' 7 week course of CRT and for an additional 4 weeks thereafter.  The study blind will remain in effect until completion of the trial.  

"This initial dose-ranging clinical trial was specifically designed to examine 3 dose levels of SGX942 versus placebo and, if statistically justified, to continue enrollment in any patient/dose groups in which there was promise of potentially demonstrating a positive and clinically-meaningful outcome," stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix.  "This positive recommendation from the DRC will allow for a sufficient number of subjects to be enrolled into the most promising dose group to increase the potential of demonstrating a positive effect with SGX942 on this catastrophic side-effect of cancer treatment that remains a significant unmet medical need."

Dr. Straube continued, "Given the additional subjects to be enrolled and our primary endpoint assessment through 11 weeks, timing to top-line results may move into the second half of this year."

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies.  It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia.  The gastrointestinal damage causes severe diarrhea.  These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system.  Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in head and neck cancer is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe.  Oral mucositis almost always occurs in patients with head and neck cancer treated with chemoradiation therapy (>80% incidence of severe mucositis) and is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in head and neck cancer remains an area of unmet medical need where there are currently no approved drug therapies.  

About SGX942

SGX942 is an innate defense regulator (IDR), a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity.  IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  SGX942 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections.  SGX942 and related analogs has a strong intellectual property position, including composition of matter.  SGX942 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development to date, inclusive of government grants.

SGX942 has received fast track designation from the US Food and Drug Administration (FDA) for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients.  Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.  Fast track designation is designed to facilitate the development and expedite the review of new drugs.  For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX942 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission.  Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense.  Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.

Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates.  The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™.  Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation XON, +1.25% focused on the joint development of SGX101 for the treatment for melioidosis.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.



To view the original version on PR Newswire, visit:www.prnewswire.com/news-releases/...er-patients-300044014.html

SOURCE Soligenix, Inc.

Copyright (C) 2015 PR Newswire. All rights reserved
Stock References

   XON
   +0.60 +1.25%

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der chart spricht bände. seit anfang des jahres verdoppelt.

www.soligenix.com/prod.shtml

sierraworldequityreview.blogspot.de/2015/...p-to-purchase.html

heute 7500 Stk. um $2,25 verkauf; 2012 um $0,60 gekauft - SUPER!

www.otcmarkets.com/stock/SNGX/news/...isease?id=101860&b=y

www.finanzen.net/analyse/Soligenix_Buy-Maxim_Group_597924

www.analystratings.com/articles/...y-rating-on-soligenix-sngx/

ein feines Investment gefunden . Läuft, too Sache.  

ganz schön heftig. Mein beileid an alle investieren.  

finviz.com/quote.ashx?t=SNGX

Chart erscheint interessant ...

Vielleicht kann jemand etwas zur Pipeline anmerken

www.soligenix.com/pipeline-programs/

insbesondere SGX301 T-Cell Lymphoma ...

Ist auch ein Impfstoff-Zock auf Covid in der klinischen Erprobung im frühen Tierstadium.

Es kommen einige Meldungen in den nächsten Monaten und die Marktkapitalisierung ist unter 50 Millionen Dollar. Allerdings scheint wohl ein ATM zu laufen ...

Das sind die Gründe für ein kleines Investment hier. Allerdings ist es für mich auch nur ein kurzfristiger Covid-Zock, d. h. bis zu einer Meldung hierzu.

Und wie jeder sehen kann, der sich den Chart anschaut, hat das Unternehmen noch nie etwas geliefert und ist eine einzige Kapitalvernichtung in der Historie.

Keine Kaufempfehlung!

ir.soligenix.com/download/...rporate+Presentation+04.30.20.pdf

Interessant sein,  Problem für den Kurs ist die dünne Kapitaldecke.  

finance.yahoo.com/news/...rna-covid-19-vaccine-130000898.html

We also continue to progress our pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) study for SGX942 (dusquetide), for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.  With enrollment of 268 subjects completed, top-line final results continue to be expected before the end of the year."

http://ir.soligenix.com/...s-And-Third-Quarter-2020-Financial-Results

Phase3 Studie SGX942 floppt 

www.rttnews.com/3155582/...istically-significant-benefit.aspx

so genau wollte ich das gar nicht wissen!

kommt wohl wieder zurück

ich bin schon dabei, nach den Handelszahlen müssen eigentlich etliche hier investiert sein

USA ist in den letzen Tagen sehr hoch, mehr als 10 Millionen am Tag, die Aktie wird schon sehr stark getradet.  

HyBryte (SGX301) Zulassungsantrag soll erst in H1/22 gestellt werden, statt wie bisher geplant als "fortlaufende Einreichung des Antrages". Damit verschiebt sich auch eine mögliche Zulassung (auf mind. H1/2023)
www.benzinga.com/general/biotech/21/05/...on-submission-for-h

RTF Letter

Die FDA hat den Zulassungsantrag des Arzneimittels von HyBryte zur Behandlung von kutanem T-Zell-Lymphom abgelehnt

"Nach einer vorläufigen Prüfung stellte die FDA fest, dass die am 14. Dezember 2022 eingereichte NDA nicht vollständig genug war, um eine inhaltliche Prüfung zu ermöglichen."

ir.soligenix.com/...he-Treatment-of-Cutaneous-T-Cell-Lymphoma

• um eine NDA-Einreichung für HyBryte zu akzeptieren, verlangt die FDA positive Ergebnisse aus einer zweiten klinischen Studie zusätzlich zu der Phase-3-FLASH-Studie, die zuvor in dieser Indikation durchgeführt wurde
  

ir.soligenix.com/...-Provides-Regulatory-Update-on-HyBryte-TM