600% Kurspotential YM Biosciences 911799

MISSISSAUGA, Canada – May 24, 2007 – YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, and its majority owned subsidiary, CIMYM BioSciences Inc. today announced that the manufacturing facility for nimotuzumab, the Company’s humanized monoclonal antibody for the treatment of cancer, has been successfully scaled up to a 500 litre-capacity continuous perfusion fermentation process.



YM also reported that Health Canada has issued a No Objection Letter for the product manufactured at the 500 litre capacity to be used in clinical trials in Canada. A competent regulatory authority in the EU has also inspected and certified the manufacturing process and infrastructure at the Center for Molecular Immunology. A further increase in the manufacturing capacity to 1,000 litre scale continuous fermentation is also anticipated to be completed in 2007.



Nimotuzumab is manufactured in a continuous process using a stirred tank perfusion bioreactor. This production method delivers higher production capacity than batch production in bioreactors of the same size.



“The 500 litre-capacity fermentation process is sufficient for the initial commercialization of nimotuzumab. This drug is also being manufactured for other licensees at Biocon Biopharmaceuticals Limited, a subsidiary of Biocon Ltd. in Bangalore, India and at Biotech Pharmaceuticals Limited in Beijing, China, where production is anticipated to start shortly,” said David Allan, Chairman and CEO of YM BioSciences.

Sieht ja prima aus! :-) Ziehen zum Wochenschluß noch mal kräftig an, kommt da etwa was am Montag?

Performance eher enttäuschend!
Kaum Umsätze!
Keine neuen Nachrichten!

Was ist da los?
Für mich ist das zurzeit eher Roulett als eine Geldanlage!
Wie seht ihr die kurz- bzw. mittelfristige Entwicklung bei YM?

schon etwas merkwürdig! Was soll man davon halten!?
www.cortalconsors.de/euroWebDe/...0&id_name=ISIN&exchange=ASE

was war das für ein Sprung gerade!? Kommt da heute was!?

YM BioSciences says FDA clears IND application for painkiller AeroLEF

LONDON (Thomson Financial) - Oncology company YM BioSciences Inc (Nachrichten) said the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for painkiller AeroLEF.

Chairman and CEO David Allan said: 'Under this IND, YM plans to initiate an open-label phase II trial designed to expand the target patient population of AeroLEF and in parallel is planning an end of phase II meeting with the FDA to gain agreement on the design of the phase III program.'

AeroLEF is an inhaled-delivery composition of free and iposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.

TFN.newsdesk@thomson.com

apm/tsm/jfr

COPYRIGHT

Copyright AFX News Limited 2007. All rights reserved.

na mal schauen ob somit mal die 2 $ nachhaltig genommen wird?

zweimal dicke Batzen zu 1,87 und 1,85 $, hoffentlich ist das kein schlechtes Zeichen!?

UBS Analysten sagen auf Ihrer Intranet Seite "strong buy" ...
gut was diese Meinung Wert kann natürlich nicht beurteilen ...
Ich hoffe das Sie recht haben und das sich mein Risiko gelohnt hat...
ich steige auf jeden Fall nicht vor 3€ aus ... das sehen wir noch bis Ende 2007

”These two studies provide independent confirmation of earlier research indicating that nimotuzumab directly binds to the EGF receptor,” said Dr. Igor Sherman, Director of Clinical Research at YM BioSciences. ”The very rare incidence, in patients treated with nimotuzumab, of the commonly seen side-effects of EGFr-targeting therapy, such as rash and diarrhea, has raised questions about whether nimotuzumab is truly interacting with the EGF receptor. The data presented at SBNet provides further evidence that nimotuzumab binds to the receptor, while the independent data from Kinki and Kyoto demonstrated the synergistic effect of nimotuzumab and radiation on cancer cells and inhibition of EGFr down-stream signaling in the presence of nimotuzumab.”



“We conclude that nimotuzumab behaves no differently than the other EGFr-targeting antibodies and that the limited and rare incidences of the debilitating side-effects that are commonly seen with other antibodies and small molecules targeting the tyrosine kinase pathway indicates that nimotuzumab has the prospect of being “best-in-class” without compromised efficacy,” said David Allan, Chairman and CEO of YM BioSciences.

The treatment phase of the study began in the post-anesthetic care unit (PACU) after completion of surgery when patients reported a pain intensity score (PI) of at least 2 (moderate pain) on a 4-point verbal rating scale [0 (none) to 3 (severe pain)]. The clinical trial study period was up to 12 hours and patients were allowed to self-administer AeroLEF™ to treat up to two additional pain episodes during the study period.  For each pain episode, patients were instructed to continue the self-administration of drug until achievement of one of the following endpoints: achievement of effective analgesia, completion of full dose, or onset of dose-limiting side effects.  Patients were allowed rescue medication at any time following initiation of study treatment.



For the first dose administered in the PACU, the percentage of patients reporting a pain intensity (PI) score of less than or equal to 1 (mild pain or no pain) at the end of the dosing period with AeroLEF™ was 59%, a statistically significant difference from placebo (27%) (p=0.005). As well, the percentage of patients reporting a pain relief (PR) score of more than or equal to 2 (moderate, lots or complete relief) at the end of the dosing period with AeroLEF™ was 60%, also statistically significant compared to placebo (32%) (p=0.0166).



Both the TOTPAR4 (total pain relief over 4 hours, summed pain relief scores) and SPID4 (summed pain intensity difference scores patients report over first 4 hours after initiation of dosing) values for the first dose of AeroLEF™ showed statistically significant differences over placebo (p<0.02), consistent with the outcome of the primary endpoint. Across the entire study, for up to three dosing sessions with AeroLEF™, self-declared effective analgesia occurred within six minutes in 25% of patients, within 11 minutes in 50%, and within 20 minutes in 75%. Patients receiving AeroLEF™ in the blinded portion of the trial reported a mean duration of effective pain relief time of 237 minutes (~4 hours) for the first dose. Similar means were observed across subsequent doses of AeroLEF™; 229.2 minutes and 243.5 minutes for doses two and three, respectively.



Administration of AeroLEF™ in this study resulted in no unexpected adverse safety events.  Attributable adverse events (AEs) observed were generally consistent with typical opioid adverse effects seen in the immediate post-operative period.    Treatment-emergent AEs were similar between treatment groups: 70.8% in the AeroLEF™ group compared with 67.6% in the placebo group. The majority of adverse events were mild in intensity. Opioid antagonists (interventional medication commonly necessary in studies of opioids) were not administered to any subjects in the trial. AeroLEF does not appear to increase the risk of key adverse events (such as hypoxia and bradypnea) and has the potential to minimize certain otherwise expected adverse effects of interest to patients and physicians, warranting further investigation and development.



“These results, from this difficult to treat patient population, confirm that patients are able to personally select doses of opioids to match the quantity of relief to the intensity of each pain event while maintaining a favorable safety tolerability profile,” said Diana Pliura, Executive Vice President of YM BioSciences. “This is robust confirmation that our approach not only provides rapid onset of pain relief, but permits extended duration of pain relief, while permitting patients to determine their own dosing requirements, and strongly supports our rationale for the expansion of development of this drug into the U.S.”



YM further anticipates conducting an End-of-Phase II meeting with the FDA to discuss Phase III trial designs for registration. In addition, YM recently received clearance from the FDA to initiate a Phase II trial in the U.S. in patients who are either opioid tolerant or opioid naïve, where a successful trial would further extend the utility and medical breadth of the product if and when approved.  This trial is expected to initiate enrollment of its 50 patient target in the second half of 2007. The principal coordinating investigator is Eugene Viscusi, MD, Director, Acute Pain Management, Department of Anesthesiology, Jefferson Medical College, at Thomas Jefferson University, Philadelphia, Pennsylvania.  Dr. Viscusi has published extensively in pain management world-wide.



“Results of this study were significant both clinically and statistically, and highlight the competitive advantages of our product and its potential as a best-in-class treatment for pain,” said David Allan, Chairman and CEO of YM BioSciences. “We are very pleased that our upcoming trial will be led by a key opinion leader in the U.S. and look forward to discussions with regulatory authorities on the path to approval for our drug.”



The Phase IIb clinical study (DLXLEF-AP4) was a 2-part, multi-center study to evaluate the efficacy, safety and tolerability of repeated, self-titrated inhalation of AeroLEF™ for the treatment of acute post-operative pain following orthopedic surgery. The first phase of the study (Part 1) was a 21 patient open-label, lead-in phase to ensure consistency of AeroLEF™ administration across study sites. Results of Part I of the Phase IIb study were presented at the 2006 American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, IL. The second phase (Part 2) was a 99 patient, randomized, placebo-controlled portion of the trial.

Positive European data from a completed second line 47-patient Phase II nimotuzumab monotherapy trial in recurrent pediatric glioma were most recently summarized in an oral presentation at ASCO 2007.  The clinical benefit rate of 38% after 8 weeks, including partial responses and stable disease, for patients with recurrent DIPG in this study represents a unique observation in these end-stage patients and has generated considerable interest.



More than half of the high-grade brain cancers or gliomas over-express epidermal growth factor receptor (EGFR) and for the most advanced brain cancers, glioblastoma multiforme (GBM), the level of expression is even higher.  A study involving 29 adults with newly diagnosed high-grade gliomas, including both anaplastic astrocytomas (AA) and GBM, who were treated with surgery, external beam radiotherapy and nimotuzumab showed that the treatment was well tolerated, the median survival time was 17.5 months for the GBM patients, and has not yet been reached for the AA patients.

Während die Anleger ob der enormen Verluste noch ihre Wunden lecken, hat YM-Vorstandschef David Allan seinen Optimismus bereits wiedergefunden. Im Gespräch mit dem AKTIONÄR bezeichnete er Tesmilifene als „ein faszinierendes Medikament“, das „hinsichtlich seiner Wirkungsweise einzigartig“ sei. Zur Erinnerung: Tesmilifene sollte bei der Behandlung von Brustkrebs eingesetzt werden und dabei helfen, Resistenzen gegen die Standardmedikamente zu verhindern. In den früheren Phasen der klinischen Studien hatte die Arznei sehr ermutigende Resultate geliefert. Warum bei den Phase-III-Tests nun nicht die gewünschten Ergebnisse erzielt wurden, soll bis Jahresende herausgefunden werden. Allan äußerte die Vermutung, dass die Zusammensetzung der Chemotherapie das Ergebnis negativ beeinflusst haben könnte. Aus diesem Grund wird bei Phase-III-Tests, die der Pharmakonzern Sanofi-Aventis mit Tesmilifene in Europa durchführen will, ein anderes Zellgift benutzt. Die Studien sollen demnächst beginnen, das Patienteneinschlussverfahren ist beinahe beendet. Zum Jahresende will YM Biosciences dann alle Erkenntnisse rund um Tesmilifene abschließend auswerten und einen Entschluss über das weitere Vorgehen treffen. Klare Tendenz derzeit: Es geht weiter.

Klassenbester?
Doch selbst wenn die Entwicklung von Tesmilifene eingestellt werden sollte, hat YM Biosciences noch weitere Pfunde, mit denen die Firma wuchern kann. Als größten „Value-Driver“ für YM sieht Allan dabei Nimotuzumb an. Der Antikörper wird derzeit in zwölf klinischen Studien auf seine Wirksamkeit bei unterschiedlichen Krebsarten getestet. Mit Nimotuzumab will YM gegen große Konkurrenten wie Amgen oder Imclone antreten – und sieht dabei durchaus Chancen, gegen die Großen zu bestehen. Denn was Nimotuzumab in den bisherigen Tests vor allem ausgezeichnet hat, ist die Tatsache, dass die gravierenden Nebenwirkungen der Konkurrenzpräparate wie ein schwerer akneartiger Ausschlag im Gesicht und am Körper bei der Behandlung mit dem YM-Produkt beinahe gänzlich ausgeblieben sind. Allan ist davon überzeugt, mit Nimotuzumab einen potenziellen Blockbuster in der Pipeline zu haben. Dafür spreche auch, dass sich der japanische Pharmakonzern Daiichi Sankyo bereits die Rechte an dem Antikörper für Japan gesichert habe. Auch die Japaner seien davon überzeugt, dass Nimotuzumab das beste Medikament seiner Klasse werden könne und auf lange Sicht den Markt dominieren werde.

Einen riesigen Markt sieht Allan auch für das neuartige Schmerzmittel AeroLEF. Allein in den USA gebe es mehr als 220 Millionen Menschen, die von ihren Ärzten jährlich mit Opioiden behandelt würden. Mit AeroLEF, so es denn zugelassen wird, erhielten die Patienten ein komplett neues Schmerzmittel, dessen Vorteile laut David Allan klar auf der Hand lägen: „AeroLEF ist eine Kombination aus freiem und Liposomgekapselten Fentanyl, die über die Atemwege aufgenommen werden kann. Das freie Fentanyl sorgt für eine rasche Wirkung, durch das Liposom-gekapselte Fentanyl hält diese über mehrere Stunden an. Da Schmerz sehr subjektiv ist und sich Ärzte bei der Dosierung des Schmerzmittels schwertun, kann der Patient bei AeroLEF die richtige Dosierung mittels eines Inhalators selbst bestimmen.“ Der Fahrplan für die weitere Entwicklung von AeroLEF sieht vor, dass zum Ende dieses beziehungsweise zum Anfang des kommenden Jahres die dritte und entscheidende Phase der klinischen Studien beginnen soll.

Für Hartgesottene
Anleger, die nach dem Kurssturz die Aktie gehalten haben, sollten dies auch weiter tun und auf positive Ergebnisse mit Nimotuzumab und AeroLEF oder sogar auf ein Comeback von Tesmilifene hoffen. Das aktuell niedrige Niveau macht das Papier auch für extrem risikobereite Neueinsteigerinteressant.

Kursziel bei YM Biosciences: 2,00 Euro. Stopp: 0,90 Euro.

da mal wieder ein Artikel erschienen ist :-)

ist doch nichts Neues, hatte ich auch schon vor Monaten gepostet das Sanofi-Aventis da noch dran ist! Traurig das erst die Leute immer kaufen wenn mal wieder was im Aktionär steht, statt sich mal selbst etwas zu informieren und Firmen zu beobachten!  

Ganz so kannst Du es nicht sehen.
In den USA nehmen die Volumen ja auch zu und die Kurse steigen, die haben dort aber keinen "Aktionär".
Ist ja aber auh egal, hauptsache es geht endlich aufwärts.
Buchhalterisch bin ich 70% mit dieser Aktie im Minus.
Stimmt, ich ätte ja schon früher aussteigen können, aber ich denke, bei solchen Titeln kann man bei Erfolg ein vielfaches in kurzer Zeit verdienen, mit hohem Risiko eben, dass es so wie zur Zeit eben nach hinten los geht.
Bin aber sehr zuversichtlich, dass irgend ein Test positiv abschliessen wird.

   "The clearance of this US IND by the FDA is a significant step in the
development of nimotuzumab," said David Allan, Chairman and CEO of YM
BioSciences. "In addition to the US investigatory sites, the global
development program for nimotuzumab includes ongoing and planned clinical
trials involving this and various other indications of cancer in Canada,
Europe, Japan, Korea, Singapore, India, Argentina, and Brazil."
   The trial design is based on a previous trial conducted in Germany. In
that trial, which was the subject for an oral presentation at ASCO 2007, eight
of 21 children with recurrent DIPG had a clinical benefit from treatment with
nimotuzumab as monotherapy - one Partial Response (PR) and seven Stable
Disease (SD) were reported in 21 patients, at the end of the induction phase
at the eighth week. Those eight patients continued on maintenance therapy and,
at week 21, three patients were declared PR and one was evaluated SD. No
reports of OR in this patient population has, to the knowledge of the Company,
been previously reported.
   The primary endpoint of the current trial is Response Rate, with a target
of 15%, and recruitment is expected to be completed within approximately
18 months from initiation. The principal investigatory site is the Hospital
for Sick Children in Toronto, Canada where Drs. Eric Bouffet, Sylvain
Baruchel, and Ute Bartels lead the international program. The US investigatory
sites at which the trial will be conducted include leading pediatric
neuro-oncology centers that are members of the "POETIC" consortium (Pediatric
Oncology Experimental Therapeutics International Consortium). Members of
POETIC include Vanderbilt Children's Hospital/Vanderbilt-Ingram Cancer Center,
M.D. Anderson Cancer Center, Memorial Sloan-Kettering Cancer Center, the
Sidney Kimmel Cancer Center at Johns Hopkins, Children's Healthcare of Atlanta
at Egleston, the Children's Hospital at the University of Colorado and the
University of Florida and Alberta's Children's Hospital in Calgary. In
addition, the University of Rochester Medical Center and the New York
University Medical Center will also be included in the trial.
   YM BioSciences' European partner for the development of nimotuzumab,
Oncoscience AG, recently announced the enrolment of the 40th and final patient
in its international Phase III trial combining nimotuzumab with radiation for
the first-line treatment of children and adolescents with newly diagnosed
DIPG.

Quelle:PR Newswire

jup sehe ich auch so, wenn ich mich an Biolitec erinnere ;-) damals rein zu 4€, dann Kurssturz bis 1,2€ und jetzt bei 15€

Und wie schon in meinen ersten Postings in diesem Thread, bin hier von Anfang an langfristig rein.

greetz und schönes Wochenende

The Phase I component enrolled patients at three centers in Canada and is evaluating the safety and feasibility of administrating nimotuzumab at three dose levels (100mg, 200mg and 400mg weekly) with palliative radiation (30 Gy in 10 fractions). The data will be used to select the optimal effective dose for the randomized Phase II component of the study, in which Overall Survival will be the primary endpoint.



Of the six patients enrolled in the 1st cohort (100mg), four Partial Response (PR) and two Stable Disease (SD) were reported as at August 14, 2007. Median Overall Survival of the group was 41.5 weeks. All patients ultimately progressed. Two severe adverse events have been reported, neither causally attributable to nimotuzumab. A notable absence of grade III/IV rash or diarrhea in this cohort was reported.



Of the seven patients enrolled in the 2nd cohort (200mg) of the study, two PR and five SD were reported as at August 14, 2007 Median overall survival of the group has not been reached but currently exceeds 25 weeks. There has been a notable absence of grade III/IV rash or diarrhea reported in this cohort.



Enrolment is now ongoing into the third cohort, to be treated at 400 mg per dose level, and accrual is anticipated to be completed by the end of 2007.





YM is conducting the trial in Canada and Kuhnil Pharmaceutical Co. is conducting a parallel trial in Korea with a common protocol. This structure is designed to accelerate overall recruitment and lower the costs to the participants. The interim report from Phase I Korean patients is anticipated early in 2008.



The poster presentation is entitled “Preliminary Results Of An Escalating Dose [Phase I /II Clinical] Trial Of The Anti EGFR Monoclonal Antibody Nimotuzumab In Combination With External Radiotherapy In Patients Diagnosed With Stage IIB, III or IV NSCLC Unsuitable For Radical Therapy” by Gwyn Bebb,  Colum Smith, Anthony Brade, Stewart Rorke and Igor Sherman. The poster, P3 – 023, will be on display on September 5 & 6 at Atlantic Halls 5 – 8 in poster session 3 - Novel Therapeutics: Molecular Therapeutics.

jup die Aktie bis jetzt auch schön im Plus :-)

naja unter schön im Plus verstehe ich allerdings was anderes! Im Augenblick dümpelt sie nur so daher, heute + 5 % morgen - 5 %, geringe Umsätze usw.! Eigentlich müste es mal wieder richtig aufwärts gehen, bis 2 € iss noch weit!

Echt ein Witz diese Aktie! Andere Aktien wären nach den Meldungen der letzten Tage um 10 - 20 % gestiegen! Für diesen Wert interessiert sich anscheinend keine Sau! :-(

wenn man diese Zeilen liest .. siehe erstes Posting ..
dann merkt man daß die  Ana...   oder wie die auch heißen mögen .. keine ahnung haben  . oder meinten die evtl. Kurspotential über die nächsten 1000 Jahre ? .. den Zeitraum verschweigt man ja lieber gerne ..