immer weniger, heute ja schon fast eingeschlafen! Auch bei den Amis kaum was los!  

MISSISSAUGA, Canada; TOKYO, Japan – April 16, 2007 – YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced the approval by Japanese regulatory authorities of an IND application to start a Phase I clinical trial of nimotuzumab for the treatment of solid tumours. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR).



“The opening of this trial confirms that we have a robust, worldwide development program for nimotuzumab,” stated David Allan, CEO of YM BioSciences and its majority owned subsidiary, CIMYM Biosciences. “Daiichi Sankyo is now established as a leading contributor within the global consortium developing this important drug.  We anticipate substantial collaborative efforts going forward as we move the product toward approvals in first world countries.”



Japanese licensee of nimotuzumab, Daiichi Sankyo Co., Ltd. has advised CIMYM Biosciences of the completion of the 30 day review period for their IND application.  The acceptance of this IND application is the first step in a significant expansion of the development program for nimotuzumab. The primary endpoint of the initial study is a regulatory requirement to first show safety in the Japanese population. The approved study will enrol a maximum of 20 patients with various solid tumours. The Japanese development program will then expand into multiple exploratory studies in several indications that will be identified as they are opened in Japan.



Nimotuzumab is approved in India, China, Cuba, Argentina and Columbia for Nasopharyngeal and/or Head & Neck cancer depending on the country.  The development program for nimotuzumab includes ongoing studies in Pediatric Pontine Glioma, NSCLC, Head & Neck, Breast, Cervical, Prostate and Esophageal cancers. A trial in colorectal cancer in North America is currently in design.

 

mehr! Da sind mal eben 20.000 Stck. zu 1,25 weggegangen  

http://www.iii.co.uk/news/...6064664&subject=companies&action=article  

nutzen jetzt einige die Gelegenheit zum Ausstieg oder wie soll ich die augenblicklichen Transaktionen verstehen!?  

lachhaft!  

Wer zuletzt
lacht,lacht am Besten  

ob das heute nur das Vorspiel war!? Scheint doch wieder mehr Optimismus aufzukommen, Potenzial steckt alle mal drin, allein schon durch den übertriebenen Absturz! Demnach dürften die 2 € eigentlich kein Problem sein!  

mit Microvision bin ich da nach einem Jahr auch gut gefahren. Hatte dort ähnlich hohe Verluste und nun bin ich schon auf der Gewinnerseite. Vielleicht gehts mit YM gleich gut...  

Kurs 1,35 mit Ziel 2,40  

Heute wird anscheinend wieder schön eingesammelt! Bei 1,35 gedeckelt und nach unten bei 1,30! Anscheinend möchte da jemand noch günstig rein und den Kurs nicht treiben durch seine Käufe!  

in den USA, sieht also gut aus für die 2$ heute  

 

:-) :-) :-)  

Es geht weiter

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.  

wie vorgestern, Kurs bei 1,48 und 1,54 abgesichert und dazwischen wird eingesammelt, sieht also weiterhin gut aus! :-)  

Habt Ihr bei 1,50 € verkauft? Ich dachte das es weiter nach oben geht. Doch jetzt wieder 1,30 €. Hat jemand neue News?  

MISSISSAUGA, ON, May 2 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced top-line results from its randomized, placebo-controlled Phase IIb trial of AeroLEF(TM) in opioid naive patients with post-operative pain following orthopedic surgery. AeroLEF(TM) met the primary endpoint of the study, showing a statistically significant difference in SPRID4 from placebo (p=0.0194).

AeroLEF(TM) is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. Unlike fixed dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF(TM) is being developed as a non-invasive patient self-titrated delivery system designed to enable patients to identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.

The trial evaluated the SPRID4 for AeroLEF(TM) compared with placebo for the treatment of the first pain episode. SPRID4 is a summary of the combined changes in pain relief and in pain intensity that patients report over the first 4 hours following initiation of dosing. The trial also examined a number of secondary endpoints including various measurements of pain relief, pain intensity, as well as onset and duration of analgesia, that are commonly used as indicators of efficacy for acute pain products. Various safety measurements were also examined.

'These results continue to demonstrate the unique potential for AeroLEF(TM) to be further developed into a valuable product for pain management across a broad range of indications, which could include post-operative pain, medical emergency pain and breakthrough pain,' said David Allan, Chairman and CEO of YM BioSciences. 'We look forward to completing a detailed analysis of the numerous secondary endpoints and safety data from this study to extend the information we will make available. These results will also be used to enhance the design of the additional Phase II trial that we are planning for the U.S. as well as the eventual Phase III trial.'

Clinical Trial Design

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(TM) for the treatment of acute post-operative pain following orthopedic surgery. Part 1 of the study was a 21 patient open-label, lead-in study to ensure consistency of AeroLEF(TM) 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.

Part 2 was a 99 patient randomized, placebo-controlled study. The treatment phase of the study began in the post-anesthetic care unit (PACU) after completion of surgery when the patient 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(TM) to treat up to two additional pain episodes during the study period.

 

war ja auch zu erwarten nach den letzten Anstiegen!

MISSISSAUGA, Canada – May 2, 2007 – YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced top-line results from its randomized, placebo-controlled Phase IIb trial of AeroLEF™ in opioid naïve patients with post-operative pain following orthopedic surgery. AeroLEF™ met the primary endpoint of the study, showing a statistically significant difference in SPRID4 from placebo (p=0.0194).



AeroLEF™ is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. Unlike fixed dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF™ is being developed as a non-invasive patient self-titrated delivery system designed to enable patients to identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.



The trial evaluated the SPRID4 for AeroLEF™ compared with placebo for the treatment of the first pain episode. SPRID4 is a summary of the combined changes in pain relief and in pain intensity that patients report over the first 4 hours following initiation of dosing. The trial also examined a number of secondary endpoints including various measurements of pain relief, pain intensity, as well as onset and duration of analgesia, that are commonly used as indicators of efficacy for acute pain products. Various safety measurements were also examined.



“These results continue to demonstrate the unique potential for AeroLEF™ to be further developed into a valuable product for pain management across a broad range of indications, which could include post-operative pain, medical emergency pain and breakthrough pain,” said David Allan, Chairman and CEO of YM BioSciences. “We look forward to completing a detailed analysis of the numerous secondary endpoints and safety data from this study to extend the information we will make available. These results will also be used to enhance the design of the additional Phase II trial that we are planning for the U.S. as well as the eventual Phase III trial.



Clinical Trial Design

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.  Part 1 of the study was a 21 patient open-label, lead-in study 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.



Part 2 was a 99 patient randomized, placebo-controlled study.  The treatment phase of the study began in the post-anesthetic care unit (PACU) after completion of surgery when the patient 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.  

Da warste wohl etwas schneller! :-)
Sieht doch wirklich gut aus, jetzt ist ersteinmal Ruhe eingekehrt und wenn die Amis wach werden nachher gehts weiter!  

 

irgend ein Deal! Gerade sind 23.000 Stck. zu 1,85 $ weggegangen  

An der 2$ Marke wird immer mal wieder gekratzt. Wann wird Sie wohl überwunden?  

http://www.finanznachrichten.de/...ichten-2007-05/artikel-8226403.asp

Dann erklär mir mal was das heißen soll!  

bis auf die Verluste, die sind angestiegen! :-(

Net loss for the fiscal third quarter of 2007 was $8.9 million and for the year to date was $27.0 million compared to $5.8 million and $17.2 million respectively for the same periods last year.