Klein,aber fein: Adeona Pharmaceuticals

Beiträge: 87
Zugriffe: 12.359 / Heute: 2
Theriva Biologics . 1,17 +2,63% Perf. seit Threadbeginn:   ---
 
Chalifmann3:

Klein,aber fein: Adeona Pharmaceuticals

6
15.12.10 16:31
Adeona Pharmaceuticals Addresses the Needs of Large Pharma
4 comments  |  by: M. E. Garza December 12, 2010  | about: AEN     1230
About this author:

Visit: BioMedReports.Com

With a diverse clinical program looking for new treatments in several different and key central nervous system disorders, Adeona Pharmaceuticals, Inc. (AEN) has great potential and some of those programs look quite likely move into a commercial deal similar to the one the Ann Arbor-based drug development firm locked up earlier this year. That was a $17.5 million deal with Swedish drug maker Meda, but there is likely to be more where that came from.

"The drugs are extremely exciting," says James Kuo, chairman and CFO of Adeona Pharmaceuticals. "They address the needs of large pharma."

Adeona Pharmaceuticals has five drugs in various stages of development and hopes to form another similar corporate partnership or two this year. It’s too bad their depressed stock price doesn’t reflect the progress they are making in the clinic and at their laboratory.

In fact, we’ve noticed that they are starting to become a little more active in their efforts for visibility (CEO is scheduled to start making the rounds and presenting at more conferences, for instance) and maybe that will resonate more with those who follow the company and it should certainly attract new followers and investors to the stock.

Adeona Pharmaceuticals is developing innovative medicines for the treatment of serious Central Nervous System (CNS) diseases. Their primary strategy is to license product candidates that have demonstrated a certain level of clinical efficacy and develop them to a stage that results in a significant commercial collaboration – basically this means they develop their product candidates to attract large pharmaceutical partners with deep pockets.

Those looking for a good trade, need to look elsewhere. We see this as a low-risk, nice reward investment candidate. They have a robust pipeline that includes product candidates in spaces that represent some big markets and unmet needs: a prescription medical food for Alzheimer’s disease, and four drugs for multiple sclerosis, fibromyalgia, age-related macular degeneration and rheumatoid arthritis.

In May 2010, Adeona demonstrated their ability to attract a partner when they entered into a $17.5 million corporate deal with Sweden-based Meda AB for the development of their product candidate flupirtine for the treatment of fibromyalgia. They received an up-front payment of $2.5 million and are entitled to milestone payments of $5 million upon filing of a New Drug Application with the FDA for flupirtine for fibromyalgia and $10 million upon marketing approval. Adeona is also entitled to receive royalties of 7% of net sales of flupirtine approved for the treatment of fibromyalgia.
Below is a listing of the diseases and associated product candidates that they are working on. For those with nearer term potential additional comments have been included:

Treatment of fibromyalgia – Effirma (flupirtine):

•Partnered with Meda AB
•In the press release about the corporate partnership, the company stated that Meda estimates the US market for fibromyalgia to be near $1 billion at the time of potential launch of flupirtine
Dietary management of Alzheimer’s disease and mild cognitive impairment with a prescription medical food – Zinthionein (zinc cysteine):

•Enrollment is 100% complete in the clinical trial evaluating Zinthionein in patients with Alzheimer’s disease and mild cognitive impairment
•All 60 patients should complete their 6 month treatment by the end of March 2011
•They anticipate top-line clinical study results should be available after that.
•If this treatment is clinically successful, they expect to make the Zinthionein product commercially available as a prescription medical food for patients.
•The classification “prescription medical foods” is not heard about often, but in quick internet searches, prescription medical foods: 1) do have to demonstrate validated effectiveness using double-blind controlled clinical trials, 2) do have to have all of its ingredients designated as Generally Recognized As Safe (GRAS) by the FDA and 3) do need a prescription from a doctor.
•They have 5 peer-reviewed scientific articles that have recently been published supporting the role of copper toxicity and zinc deficiency in patients with Alzheimer’s disease and mild cognitive impairment.
Treatment of relapsing-remitting multiple sclerosis in women – Trimesta (estriol):

•115 of 150 patients have been enrolled in the clinical trial evaluating Trimesta in women suffering from relapsing-remitting multiple sclerosis.
•On their 3rd quarter 2010 conference call, the CEO said that they anticipate full enrollment by the second half of 2011; however, they give no assurances.
Treatment of age-related macular degeneration – ZincMonoCysteine (zinc-monocysteine):

•They continue additional work on manufacturing and scale-up of zinc-monocysteine to support the further nonclinical testing and cGMP manufacturing.
Treatment of rheumatoid arthritis – dnaJP1 (hsp peptide):

•They are currently conducting further preclinical activities and planning the clinical development strategy. In addition to drug development, AEN purchased a CLIA-certified diagnostic laboratory in July of 2009 (now called Adeona Clinical Laboratory) to measure metabolic serum zinc and copper levels. But, according to their 3rd quarter 2010 conference call, the business has really grown – the client base has increased from 5 to 9 health service providers and earlier this year the in-house diagnostic testing services were expanded to include a full array of microbiology testing. They said that these significant changes represent a 567% increase in laboratory revenues for the quarter ended September 30, 2010, compared to the same quarter in the previous year.
As of June 30, 2010, AEN emerged, for financial reporting purposes, from being a development stage enterprise with a $979,782 profit in second quarter of 2010, mainly due to the $2,125,000 of net license revenue received as a result of the Meda AB sublicense agreement.

Total net revenues for the three and nine months ended September 30, 2010, were $289,898 and $2,544,825, respectively, compared to $51,085 for both periods in 2009. The increase in total net revenues for the three months ended September 30, 2010 reflects a 567% increase in net laboratory revenues from the three months ended September 30, 2009.

The increase in total net revenues for the nine months ended September 30, 2010 reflects $2,125,000 of net license revenue received as a result of the Meda AB sublicense agreement of flupirtine for fibromyalgia during the second quarter of 2010 and increases in net laboratory revenues for expanded client services provided by Adeona Clinical Laboratory from the nine months ended September 30, 2009.

As of September 30, 2010, they had approximately $3.3 million in cash compared to approximately $2.7 million on December 31, 2009. And as reported in their 3rd quarter 2010 filing, their cash at October 31, 2010 was approximately $3.1 million.

In November 2010, an announcement came out that they were awarded two grants totaling $488,959 under the Qualifying Therapeutic Discovery Project Program to support their Alzheimer’s disease and multiple sclerosis programs currently in clinical testing. This was a pretty good amount for two clinical programs; Dr. Kuo even put it into perspective on their quarterly conference call when he said “these grants represent approximately 38% of our total research and development expenses based on trailing twelve month calculations. These grants are highly significant for us from an economic perspective, and in comparison to many of our industry peers, we appear to have covered more of our R&D spend.”

When it comes to risk-vs-reward, an investment in AEN seems like a smart play with multiple shots on goal. Best of all, the price appears to have bottomed out at these levels. In listening to Dr. Kuo on various webcasts, conference calls and presentations, things seem to be moving along and current longs seem happy with everything but stock performance- largely due to the fact that they have remained mostly undiscovered.

AEN has demonstrated success with corporate partnering, they have started actively promoting the progress and potential of the clinical programs. They have expanded current revenue potential with their own clinical lab and we see them diligently trying to preserve cash.

With several potential product candidates in the pipeline – it not only seems likely they should attract additional partners, they are actively working on it.

I’m keeping my eye on the prescription medical food, Zinthionein, for the dietary management of patients suffering from Alzheimer’s disease and mild cognitive impairment as it seems to have the most near-term milestone (Q2 or Q3 2011) and a different regulatory path through the FDA, which as we all know, can take a drug candidate years and years

MFG
Chali
Klein,aber fein: Adeona Pharmaceuticals 366111
61 Beiträge ausgeblendet.
Seite: Übersicht Alle 1 2 3 4


Werbung

Entdecke die beliebtesten ETFs von SPDR

SPDR MSCI World Communication Services UCITS ETF
Perf. 12M: +48,78%
SPDR S&P U.S. Communication Serv. Select Sector UCITS ETF Ac
Perf. 12M: +46,72%
SPDR MSCI World Technology UCITS ETF
Perf. 12M: +43,10%
SPDR S&P U.S. Consumer Discretionary Select Sector UCITS ETF
Perf. 12M: +42,59%
SPDR S&P U.S. Financials Select Sector UCITS ETF
Perf. 12M: +41,98%

Chalifmann3:

Hi bierro und Heiko

 
30.11.11 02:15
Nach dem Debakel mit zinthionein war ich enttäuscht von Adeona und bin raus ! Aber gibt es hier jetzt neues Potential ? Interessante Frage ,aber ich bin nicht mehr investiert,habe in Galena Biopharma umgeschichtet und erfreue mich da an 25% Kursplus seit gestern ! Galena ist aktuell übrigens genauso viel (wenig) wert wie Adeona,es gibt sogar einen Galena Thread hier auf Ariva,wenn ihr mal lesen wollt,aber eigentlich gehört das hier ja nicht hin,aber ich denke einfach die Aktie ist auf jeden Fall mal erwähnenswert,und wer sie noch nicht kennt ..... bitteschön!

MFG
Chali
bierro:

Verdoppler!

 
30.11.11 18:55
Wow, und heute geht´s wieder mal rund, wheeeeeeeeee!!!!!!

Chali, wo hast Du die ganze Zeit gesteckt, lange nix mehr gehört.

Und die alte Ostsemmel aus dem Harz hat mich bis hierhin verfolgt, lol.. So sieht ein Anstieg aus, Ostharzer, nicht wie bei Eurer PAK, die sich seit Monaten im Seitwärtstrend befindet.

Substanzlos, so so...
Klein,aber fein: Adeona Pharmaceuticals 462759
Heiko T.:

Neueste Meldung

 
01.12.11 17:36
Positive Clinical Study Results Reported by Adeona's Oral Zinc for ALS Collaborator

-- PNA Center for Neurological Research Clinical Study Results Presented at the 22nd International Symposium on ALS/Motor Neurone Disease --

ANN ARBOR, Mich., Nov. 30, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative disease-modifying medicines for serious illnesses, announced today that the Company's clinical collaborator for amyotrophic lateral sclerosis (ALS), PNA Center for Neurological Research (PNA), reported top-line results from its pilot Phase I/II open label, three month safety study of oral high dose zinc therapy in ALS, also known as Lou Gehrig's disease. The clinical study met its primary outcome as no safety issues related to zinc therapy were observed. In addition, an average decrease in the monthly rate of disease progression was observed in the ALS patients on zinc therapy, compared to published historical controls, as well as compared to the average monthly rate of disease progression of the subjects prior to enrollment in the study.

PNA's clinical study data was presented at the 22nd International Symposium on ALS/Motor Neurone Disease in Sydney, Australia on Wednesday, November 30, 2011 at 6:00 p.m. (Wednesday, November 30, 2011 at 2:00 a.m. Eastern Standard Time), by David S. Saperstein, M.D., and Nicole C. Hank, M.H.S.M., from PNA.

Ten patients diagnosed with sporadic ALS and on stable doses of RILUTEK® (riluzole) were enrolled in the open label, three month study of oral high dose zinc therapy. The study was conducted under an Investigational New Drug application (IND) and was registered at clinicaltrials.gov/ct2/show/NCT01259050. The rate of disease progression was measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a widely used, validated rating scale that assesses the progression of disability in patients with ALS, revised to also incorporate assessments of respiratory function. At baseline, the average ALSFRS-R score of these patients was 33 and the average time from symptom onset was one year.

Patients were administered pills containing 90mg of elemental zinc per day, as well as 2 mg of copper every other day to prevent potential copper depletion. Eight out of the ten patients enrolled completed three months of zinc therapy. Two patients dropped out within the first month for reasons unrelated to the zinc therapy. All patients reported taste disturbance (metallic taste) and two of eight patients reported nausea (both of whom were able to complete the study after reducing their dose to 60mg of zinc per day).

On average, the eight patients who completed the study lost 0.37 ALSFRS-R points per month during the three months of therapy. This represents a lower rate of monthly disease progression compared to the average 0.89 ALSFRS-R monthly rate of disease progression in ALS based on historical controls.[i] Prior to enrolling in the study, seven of the eight patients for whom previous ALSFRS-R scores were available lost an average of 0.61 ALSFRS-R points per month.

Based on these findings, the neurologists at PNA hypothesize that high doses of zinc may slow disease progress in ALS and that a larger controlled clinical trial of zinc therapy in ALS patients is warranted. Preparations are currently underway to evaluate the safety and efficacy of Adeona's proprietary drug candidate, AEN-100, a gastroretentive, sustained-release, zinc tablet, in an adaptively designed, multi-center, double-blind, placebo-controlled Phase II/III clinical trial in ALS patients to be conducted under an IND. It is anticipated that the trial will enroll approximately 65 ALS patients, who will continue on RILUTEK® (riluzole) as the standard of care treatment, and that the patients will be randomized into two treatment groups and one matching placebo group. They will receive clinical trial medications for at least six months with periodic monitoring. A small Phase I pharmacokinetic clinical trial of AEN-100 is planned for completion prior to initiating the multi-center clinical trial. It is anticipated that Adeona will provide the study medications and fund the clinical trials, which will be led by the neurology team at PNA.

"We are pleased to report that the use of zinc is safe in ALS patients, and we are also encouraged to observe that this small group of ALS patients demonstrated a reduced rate of change in their ALSFRS-R scores while taking zinc, suggesting a slower rate of disease progression," said Todd D. Levine, M.D., President of PNA, Assistant Clinical Professor at the University of Arizona, Co-Director of the Banner Samaritan ALS Center in Phoenix, Arizona and Lead Principal Investigator of Adeona's planned clinical trial. "We look forward to initiating this larger clinical trial in ALS patients and to providing Adeona's proprietary zinc-based therapy that has already demonstrated clinical evidence of being very well tolerated by patients and of providing superior bioavailability."

"Given the clinical results PNA presented today at an international symposium suggesting a safe and therapeutic role for zinc in ALS, we believe it supports our planned Phase II/III clinical trial of AEN-100 in ALS patients," said James S. Kuo, M.D., M.B.A., Chief Executive Officer of Adeona. "We are pleased to be working with the dedicated neurologists at PNA to evaluate the potentially revolutionary therapeutic benefit of AEN-100 for this devastating and fatal progressive neurological disease."

About AEN-100

AEN-100 is Adeona's patent-pending gastroretentive, sustained-release oral zinc drug candidate intended for indications in which high dose zinc therapy may be appropriate. Based upon prior studies conducted by Adeona, the Company believes that AEN-100 provides far superior gastrointestinal tolerability and once-daily dosing convenience compared to existing zinc therapy products. Gastrointestinal tolerability (namely, nausea and vomiting) represents a major dose limiting factor of oral high dose zinc therapy. Adeona also intends to file for orphan drug protection with the Food & Drug Administration (FDA) in the U.S. and European Medicines Agency (EMEA) in the E.U, which may provide for marketing exclusivity for a period of seven and ten years, respectively, following approval. In ALS, there is a demonstrated zinc binding defect of the ALS-implicated protein known as copper/zinc superoxide dismutase (SOD-1) as well as a demonstrated sequestration of zinc in the Lewy body-like hyaline inclusions that are characteristic of ALS.[ii]

About Amyotrophic Lateral Sclerosis (ALS)

ALS is a devastating progressive neurodegenerative disease that affects the motor nerve cells in the brain and the spinal cord of predominantly older people of both sexes. It is estimated that as many as 30,000 Americans may have the disease at any given time. The progressive degeneration of the motor neurons in ALS eventually leads to the death of the patient. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. When motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed.

While non-invasive ventilation and gastrostomy tubes prolong life by 6-12 months, the average lifespan from time of symptom onset is 2-5 years. Currently, RILUTEK is the only FDA-approved drug for ALS. RILUTEK is an NMDA receptor antagonist and has been shown to prolong life in patients with ALS by 3 months. Presently, there is no cure for ALS, nor is there a known cause. For more information on ALS, please visit the ALS Association website at www.alsa.org.

About PNA Center for Neurological Research

PNA Center for Neurological Research (PNA) is an independent, not-for-profit organization based in Phoenix, Arizona. PNA was established by five of the neurologists from Phoenix Neurological Associates, Ltd., who are dedicated to discovering new treatments for patients with neurological diseases. PNA's goal is to be a hub where philanthropists, advocates, organizations, family and friends of patients with a neurological illness could make donations that can support investigator-initiated clinical trials. PNA hopes to optimize proper treatments in order to improve outcomes for patients with neurological diseases. For more information about PNA, please visit its website at www.pnaresearch.org. For more information about Phoenix Neurological Associates, Ltd., please visit its website at www.phoenixneurology.com.

SOURCE Adeona Pharmaceuticals, Inc.


Read more: www.nasdaq.com/aspx/...zinc-for-als-collaborator#ixzz1fIkhdI4K
Heiko T.:

...

 
01.12.11 17:44
Adeona Reports Positive Results For Initial Zinc Trial In Lou Gehrig's Disease


(RTTNews) - Adeona Pharmaceuticals, Inc. (AEN) Wednesday said PNA Center for Neurological Research's pilot Zinc Therapy was found to be safe and recorded a slow disease progression in amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig's Disease.

The study was conducted under an Investigational New Drug or IND application and Adeona plans to begin a Phase II/III clinical trial of its zinc tablet AEN-100, and to file for orphan drug protection.

ALS is a devastating progressive neurodegenerative disease that affects the motor nerve cells in the brain and the spinal cord of predominantly older people of both sexes. It is estimated that as many as 30,000 Americans may have the disease at any given time. When motor neurons die, the ability of the brain to initiate and control muscle movement is lost. Patients in the later stages of the disease may become totally paralyzed.

According to Adeona, the average lifespan from time of symptom onset is 2 to 5 years. Rilutek is the only FDA-approved drug for ALS, prolonging life by 3 months. The pilot study enrolled ten patients diagnosed with sporadic ALS and on stable doses of Rilutek or riluzole. Eight out of the ten completed three months of zinc therapy.

Patients were administered pills containing 90 mg of elemental zinc per day, as well as 2 mg of copper every other day to prevent potential copper depletion. The rate of disease progression was measured by the ALS Functional Rating Scale-Revised or ALSFRS-R, that incorporates assessments of respiratory function. At baseline, the average ALSFRS-R score of these patients was 33 and the average time from symptom onset was one year.

At three months, the eight patients who completed the study lost on average, 0.37 ALSFRS-R points per month during the three months of therapy. This represented a lower rate of monthly disease progression compared to historical controls, which had demonstrated a average 0.89 ALSFRS-R monthly rate of disease progression.

Adeona is preparing to evaluate the safety and efficacy of its proprietary drug candidate, AEN-100, a gastroretentive, sustained-release, zinc tablet, in an adaptively designed, multi-center, double-blind, placebo-controlled Phase II/III clinical trial.

PNA's clinical study data was presented today at the 22nd International Symposium on ALS/Motor Neurone Disease in Sydney, Australia.

AEN is currently trading at $1.08, up $0.25 or 30.12%, on a volume of 1.7 million shares, on the AMEX. Over the past year, the stock traded in a range of $0.42 - $2.25.

For comments and feedback: contact editorial@rttnews.com

Read more: www.nasdaq.com/aspx/...al-in-lou-gehrigs-disease#ixzz1fInGWuu3
Chalifmann3:

Hi Heiko !

 
01.12.11 17:57
Adeona wird mit ihrer Zink-therapie diese Krankheiten wie ALS,Alzheimer etc. nicht heilen können,deshalb hab ich einen Thread zu einer anderen Aktie aufgemacht,die das in ferner Zukunft mit neuronalen Stammzellen vielleicht doch heilen können,die aktie bleibt bei mir vorerst auf Watchlist: International Stem Cell Corp (ISCO.OB)

MFG
Chali

P.S. Hi bierro ,altes Haus,was ist mal wieder mit YRCW los..... ,hahaha ?
Heiko T.:

O.k. Chali

 
01.12.11 19:04
Alzheimer 100% zu heilen,ist ja auch nicht unbedingt der Anspruch.

Danke,hab ISCO mal auf WL
bierro:

Egal...

 
02.12.11 16:39
...ob sie damit Alzheimer heilen können oder nicht, der Anstieg scheint nachhaltig.

Wir stehen heute bereits bei 1,15 USD.

Wahnsinn!
Chalifmann3:

Glückwunsch !

 
02.12.11 16:40
Hier gehts ja wirklich mal wieder gut ab,ob hier tatsächlich neues Potential entfacht ist ? Aber die Rakete Pacific Ethanol geht derzeit mindestens genaau so gut,hmhmm .... Grummel .....

MFG
Chali
Heiko T.:

JA,läuft

 
02.12.11 17:50
im Moment wirklich super.
Heute schon mal im Hoch bis 1,41.Das deutet die Richtung an.
Momentan 20% plus!

Mit Gewinnmitnahmen wird man in Zukunft immer mal rechnen müssen,aber Haupsache die Richtung bleibt.
Chalifmann3:

Brauch eure hilfe

 
02.12.11 18:13
Was haltet ihr von dem Medarex spin-off Celldex Therapeutics ? (Nasdaq:CLDX) Bin noch unsicher,aber mit einem einstieg am liebäugeln ! Celldex hat eine vielzahl von Antikörperimpfstoffen,von denen gestern einer in Phase-3 gestartet ist gegen glioblastoma! Der witz an der Sache: Celldex ist im Peer-Group Vergleich absolut günstig: Seattle Genetics (1,8 Mrd.-$) Immunogen (900 Mio.-$) Celldex (130 Mio.-$)

Gebt es Meinungen ? Die aktie ein Kauf ?!!

MFG
Chali
Chalifmann3:

AEN

 
02.12.11 18:15
Was Adeona einfach nocht fehlt,sind starke finanzkräftige Partner,die die Pipeline vorantreiben ....

MFG
Chali
Heiko T.:

Hi Chali

 
02.12.11 21:00
CLDX find ich auch ganz interessant.Hatte die mal Anfang 2010 und ca. 20% gemacht.
Sind sicherlich etwas unberechtigt abgestraft worden auch i.Z. mit dem Dendreon Verfall im August.Für 3,60 sind sie m.M. nach erst mal gut.Dann mal schauen.
Heiko T.:

Sieht heute

 
08.12.11 20:38
wieder  b l e n d e n d aus.Hat sich die letzten Tage auch eigentlich super gehalten nach dem famosen Anstieg.

Charttechnisch auch sehr gut.
Heiko T.:

Fantastisch

 
09.12.11 18:55
gestern Kaufempfehlung für Adeona in THE STREET von Stockpickr

Das Ding ist im Moment der Hit!

www.thestreet.com/_nasdaq/story/11338224/1/...ee&cm_ite=na
Heiko T.:

Kaum Abgabedruck

 
12.12.11 20:19
für AEN gewesen.
Sogar jetzt im Plus,obwohl alles andere,vor allem auch Pharma, runtergeht.
Sehr gutes Zeichen!
Heiko T.:

Erfolgreiches Neues an alle

 
04.01.12 19:50
Anfang bis Mitte Dez. hat ca.1,10 gehalten und somit wurde SKS verhindert.
Könnte jetzt wieder Ri. 1,45 laufen.
Good Luck
Heiko T.:

im Moment

 
05.01.12 21:02

1,57 

Hoch 1,60

Heiko T.:

Bin erstmal

 
06.01.12 18:05
mit durchschnittlichem Gewinn von 70 % bei 1,69 raus.
Good Luck an alle noch investierten.
Chalifmann3:

hi Heiko,bierro !

 
17.01.12 16:30
Glückwunsch zu Adeona euch beiden und allen anderen,läuft im moment echt perfekt,und keiner weiss warum,es gibt ja bald eine Namens und fokussierungsänderung ! Was ich euch sagen wollte,speziell dir Heiko,wo du jetzt investieren kannst ist Schaut euch mal Lpath inc. (LPTN.OB) an,Hammerteil ! alles weitere zu Lpath in meinem neuen Thread .....

Bis bald !

MFG
Chali
bierro:

The trend is your friend

 
18.01.12 13:13
Tach Ihr zwei,

wir sind ja scheinbar die einzigen hier. Der Aufwärtstrend scheint mir ok, deswegen hab ich gestern auch die 1,88 mitgenommen und hoffe auf weiterhin Gutes.
Heiko T.:

Hallo an alle

 
18.01.12 18:58
Danke Chali,
werd mir das mit LPTN mal überlegen.
CLDX gehen ja auch ganz gut,wie ich vermutete.

Grüße
Heiko T.:

News

 
19.01.12 20:28
Leute

Adeona Begins Phase II Trial Of Trimesta For Cognitive Dysfunction In MS

(RTTNews.com) - Adeona Pharmaceuticals, Inc. (AEN) announced the initiation of the Phase II clinical trial of Trimesta (oral estriol) for treating cognitive dysfunction in multiple sclerosis, or MS.

The new Phase II clinical trial is a randomized, double-blind, placebo-controlled trial intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients. Subjects will be equally randomized to receive either once-daily Trimesta or matching placebo. The primary outcome measure is the average change in PASAT scores at 12 months between each group. Secondary outcome measures include relapse rates, whole brain atrophy determined by MRI and safety.

Dr. Voskuhl, Principal Investigator, said, "We are very excited to initiate patient enrollment in this novel clinical trial of Trimesta in which the primary endpoint is improvement in cognition. Statistics show that 50-65 percent of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed. Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability. The goal of this trial is to address this unmet need for MS patients, potentially improving a person's mental sharpness and ability to continue working."

For comments and feedback: contact editorial@rttnews.com

www.rttnews.com




Adeona Announces Initiation of Phase II Clinical Trial of Trimesta™ for Cognitive Dysfunction in Multiple Sclerosis


ANN ARBOR, Mich., Jan. 19, 2012 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses, announced today the initiation of the Phase II clinical trial of Trimesta™(oral estriol) for the treatment of cognitive dysfunction in multiple sclerosis (MS). This clinical trial is intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients at University of California, Los Angeles (UCLA) and is being conducted at by Principal Investigator, Rhonda Voskuhl, M.D., Director, UCLA Multiple Sclerosis Program, Department of Neurology. There is currently no approved therapy for the treatment of cognitive dysfunction in MS.

"We are very excited to initiate patient enrollment in this novel clinical trial of Trimesta in which the primary endpoint is improvement in cognition. Statistics show that 50-65 percent of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed. Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability," said Dr. Voskuhl, Principal Investigator. "The goal of this trial is to address this unmet need for MS patients, potentially improving a person's mental sharpness and ability to continue working."

This randomized, double-blind, placebo-controlled Phase II clinical trial is based on findings from a previously completed 10-patient, single-agent, crossover Phase I/II clinical trial conducted by Dr. Voskuhl and colleagues at UCLA. The results from the Phase I/II trial demonstrated a statistically significant 14% improvement from baseline in Paced Auditory Serial Addition Test (PASAT) cognitive testing scores in relapsing-remitting MS patients after six months of Trimesta™ therapy (p = 0.04). The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability and is widely used in MS to measure cognitive function. Estriol has also been shown to have neuroprotective benefits in animal models of MS, a property not generally shared by currently approved MS therapies.[ii]

The new Phase II clinical trial is a randomized, double-blind, placebo-controlled trial intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients. Subjects will be equally randomized to receive either once-daily Trimesta™ (oral estriol) or matching placebo. The primary outcome measure is the average change in PASAT scores at 12 months between each group. Secondary outcome measures include relapse rates (the primary endpoint of the ongoing Phase II clinical trial of Trimesta™ for relapsing-remitting MS), whole brain atrophy determined by MRI and safety. Charitable organizations have pledged to financially support a majority of the new MS clinical trial. Detailed information regarding this clinical trial, including contact information for the clinical site, is available at www.clinicaltrials.gov/ct2/show/NCT01466114.

In addition to the clinical trial of Trimesta for cognitive dysfunction in MS, Trimesta™ is also the subject of a separate ongoing 15-center Phase II, randomized, double-blind, placebo-controlled clinical trial seeking to demonstrate Trimesta's ability to reduce relapse rates in women with the relapsing-remitting form of MS. With over $8 million in grant funding awarded to date, this separate ongoing Trimesta™ clinical trial should be funded to its completion. Additional information regarding the relapsing-remitting multiple sclerosis clinical trial is available at www.clinicaltrials.gov/ct2/show/NCT00451204.

"While our Board of Directors has strategically implemented several actions to prioritize our focus on the emerging field of synthetic biologics, our continued commitment to this important new MS clinical trial, having substantial external funding, is consistent with our mission of maintaining and building value for our shareholders," stated Jeffrey Riley, Adeona's Chairman of the Board.

About Trimesta™ (oral estriol)

Trimesta™ is Adeona's proprietary drug candidate for the treatment of relapsing-remitting MS and for cognitive dysfunction in MS, both in female patients. Estriol has been approved and marketed for more than 40 years throughout Europe and Asia for the treatment of post-menopausal symptoms. It has never been approved in the United States by the Food and Drug Administration (FDA) for any indication.

About Cognitive Dysfunction in Multiple Sclerosis

According to the National Multiple Sclerosis Society and the Multiple Sclerosis Society of Canada publication, Hold that Thought! Cognition and MS, it is fairly common for people with multiple sclerosis to complain of problems remembering things, finding the right words, concentrating on a task or something they are reading, or following a conversation. These are all cognitive symptoms of multiple sclerosis. Fifty to sixty-five percent of those affected by multiple sclerosis have cognitive dysfunction. Despite the fact that most symptoms are mild to moderate, they can have a significant impact on a person's ability to normally function. The overall cognitive dysfunction can be described as a reduction in mental "sharpness."

The major areas of cognition that can be dysfunctional include what are termed complex attention and executive functions. Complex attention involves multitasking, the speed with which information can be processed, learning and memory, and perceptual skills; executive functionsinclude problem solving, organizational skills, the ability to plan, and word finding. Just as the nature, frequency, and severity of multiple sclerosis-related physical problems can widely vary, not all people with multiple sclerosis will display these cognitive issues, and no two people will experience exactly the same types or severity of problems.


In December 2011, Adeona announced that the Board of Directors had taken several actions to prioritize the company's focus on its recent entry into the emerging field of synthetic biologics. As a result of its new primary focus, the Board approved a proposed name change of the company to Synthetic Biologics, Inc., to better reflect its new mission and primary business. Such name change is subject to stockholder approval.

Synthetic Biologics is a trademark of Adeona Pharmaceuticals, Inc.


For further information, please contact Adeona at (734) 332-7800, Ext. 22.

Sicotte, Liva, Klutch, Pfeiffer, Bouvier, Odesa, Wu, Voskuhl, Treatment of multiple sclerosis with the pregnancy hormone estriol, Ann Neurol. 2002 Oct;52(4):421-8.

[ii] Gold and Voskuhl, Estrogen treatment in multiple sclerosis, J Neurol Sci. 2009 Nov 15;286(1-2):99-103. Epub 2009 Jun 18.

SOURCE Adeona Pharmaceuticals, Inc.
bierro:

Wie geil ist das denn?

 
20.01.12 22:28
bierro:

Und dann...

 
20.01.12 22:34
...schmeißt einer 15.300 Shares. F...ck! After Hours 2,04. Aber ich denke, AEN macht ihren Weg.
Chalifmann3:

Adeona vs Astex

 
07.02.12 22:53
Hey leute,Adeona scheint grundlos heissgelaufen,es bietet sich eine erstklassige chance in die weitaus interessantere Astex umzuschichten,die heute sogar noch mal 22% billiger geworden ist ich habe einen Thread zu Astex aufgemacht !

Adeona Pharmaceuticals

My only concern for Adeona is knowing that the recent run was accompanied by modest company news, and after watching Adeona run, fall, and now running again, I'm left to wonder: Is this real? Or is this just deep pockets taking advantage of a good situation? I don't mean to sound pessimistic, but more than one quality firm has been hurt by the Market's unexplainable 'run' then 'dump', especially in the age of computer flash-crashes. Or for excited long-investors who finally see their investment going up and wake up the next morning to read that the company is diluting shares or selling equity securities but this of course is due to the company's new direction with Intrexon Corporation.

I am scratching my head over Adeona, but its pps movement demands careful attention. Up big, down big, and now up big to $2.10/share on Friday's close. Someone is making a lot of money. But here again, like Astex, no conclusive reason unless you are bullish on the stock and think it is sorely under-valued.

What I especially like is when I see a penny-land biotech improving itself and that's my interpretation of the Intrexon deal along with the impending new name signifying the new direction for Adeona. Existence is futile unless biotechs take active steps to stay one step ahead

Astex Pharmaceuticals

Among SA authors, I am a small minority who see the value in former SuperGen, now Astex. But it doesn't matter. Astex is on fire because the share price has jumped from $1.51/share on 30 November 2011 to Friday's close at $2.72/share. That is a monstrous jump in a very short two months.

As my #2 Top 3 Biotech picks, Astex is still under-valued at $2.72/share. I realize few biotechs go straight up, and retracing and accumulation may occur, but I wouldn't be surprised if Astex goes over $3/share as it hit $3.27/share on 2 June 2011. I will be more surprised if Astex doesn't go over $4/share in the coming months.

With a supplementary new drug application FDA decision ahead for Dacogen, investors are probably seeing the pps recovery and run-up going into the news. There will always be day-traders who will claim their lion's-share, but back in 2011, I observed that Astex may be a great trading stock with its variable ups and downs. Or for long-traders, sitting tight, and holding. Clearly, when it hit $1.51/share, that was a gift and congratulations to anyone who jumped in at a fabulous moment.

Still, the Market is hard to interpret and what happens after Friday's run won't be know until Monday. Yet it goes without saying that Astex is cash-flush, so I'm inclined to think the Market is returning the value to Astex that it should have been all along.

MFG
Chali
Es gibt keine neuen Beiträge.

Seite: Übersicht Alle 1 2 3 4

Hot-Stocks-Forum - Gesamtforum - Antwort einfügen - zum ersten Beitrag springen

Neueste Beiträge aus dem Theriva Biologics Inc Forum

Wertung Antworten Thema Verfasser letzter Verfasser letzter Beitrag
  21 Was war das? Eurocoin axolot 02.07.23 08:21
  3 Sehr GUTE News ! BONDJames hulkier 25.04.21 01:19
  1 Synthetic Biologics SYN Kostoleuschel Kostoleuschel 16.03.12 20:04
6 86 Klein,aber fein: Adeona Pharmaceuticals Chalifmann3 Chalifmann3 07.02.12 22:53
  13 Adeona Pharma ( WKN: A0RBK9 / AEN ) // AMEX 0815ax makumba 07.06.10 12:41

--button_text--