600% Kurspotential YM Biosciences 911799
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“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.
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.
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.
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.
Sieht doch wirklich gut aus, jetzt ist ersteinmal Ruhe eingekehrt und wenn die Amis wach werden nachher gehts weiter!
Dann erklär mir mal was das heißen soll!
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.