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MISSISSAUGA, Canada – March 5, 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 that enrolment has been completed in the randomized, double-blind, and placebo-controlled portion of its Phase IIB trial (DLXLEF-AP4) of AeroLEF™. YM expects that the results of the primary efficacy and safety analyses will be available in mid-second quarter of 2007.
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. AeroLEF™ provides both rapid and extended pain relief. 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 designed to permit patients to match dosage to their individual pain intensity for each pain episode.
“We look forward to receiving the results of this study of AeroLEF™, which in previous studies has provided highly-individualized, episode-specific pain relief in the post-operative setting,” said David Allan, Chairman and CEO of YM BioSciences. “We are continuing to assess the design of additional Phase II clinical studies and plan to file a US IND shortly. Concurrently, we will continue to educate potential development and marketing partners about the unique attributes of AeroLEF™.”
The Phase IIb clinical trial of AeroLEF™ for the treatment of moderate to severe post-surgical pain consisted of two parts. Patients who underwent a variety of elective orthopedic surgical procedures were enrolled at eight centers. Part I was an open label trial designed to allow investigators to gain familiarity with administration of the product and enrolled 21 patients. Part II was a randomized, double-blind, and placebo-controlled trial of 99 patients and was designed to evaluate the safety and efficacy of AeroLEF™ compared to placebo. The primary endpoint for this study was the Summed Pain Relief plus Pain Intensity Difference (SPRID) scores during the first four hours after the start of the initial dose. Secondary endpoints included Time to Effective Pain Relief, as well as six safety endpoints.
Dr. Diana Pliura will be presenting AeroLEF™ at the Oppenheimer Pain Management Conference at the Flatotel in New York on March 6th in a session that begins at 11:00 a.m. EST
The results of an interim analysis on the first 67 patients in Part II of this trial were released in September 2006. The data indicated that AeroLEF™ provided benefit compared to placebo but the difference between the treatment arm and placebo arm had not yet achieved the significance level predefined in the study protocol and therefore the study was continued as planned.
In Part I of the Phase IIb study, patient self-titrated dosing with AeroLEF™ provided clinically meaningful analgesia in 81 percent, 100 percent and 87.5 percent of treated pain episodes during doses 1, 2 and 3, respectively. Within 10 minutes of initiating dosing with AeroLEF™, 38 percent, 73 percent and 63 percent of patients reported a reduction in pain intensity to mild pain during doses 1, 2 and 3, respectively. Achieving effective pain relief was the reason for stopping AeroLEF™ dosing in 35 of 40 (88 percent) treated pain episodes. Study results also suggested that multiple doses of AeroLEF™ were well tolerated. No treatment emergent adverse events were reported in 9 of 21 (43 percent) of patients. The majority (>70 percent) of treatment-emergent adverse events were mild and considered typical of those associated with opioid analgesia in the post-operative setting. Adverse events of a respiratory nature were reported in 4 patients. These events were mild and transient and resolved with minimal intervention. Results of Part I of the study were presented at the 2006 American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, IL.
Mfg Jens
Und was meint Ihr?
"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."
Sanofi-Aventis wird doch nicht ohne der Meinung zu sein das es was bringt, weiter Geld reinstecken! Die scheinen also auch überzeugt zu sein das Tesmilifene Potenzial hat!
“The addition of these internationally recognized industry executives not only enhances our current management structure, but also highlights our commitment to clearly define and execute the optimal pathways for the development of both nimotuzumab and AeroLEF™,” said David Allan, Chairman and CEO of YM BioSciences. “John has planned and led successful development programs for numerous drugs and has guided products through to FDA approval and partnering. His extensive drug development experience will enable him to play a key role in driving YM’s products forward as they enter the critical stages in their clinical development. We expect Dianne’s expertise in the development of drug/device combinations for acute and chronic pain indications to prove invaluable in her oversight of the development of the AeroLEF™ program.
Dr. Waterfall was Divisional Vice-President, Global Project Management at Hoffman La-Roche Inc. with leadership responsibility through NDA filings and certain of the approvals for Xeloda™, Fortovase™, Zenapax™, Xenical™. He held senior posts at Roche between 1985 and 1999. He subsequently held the role of Research and Development Director at British-based Xenova Group plc where he was responsible for its portfolio of biologics and small molecules with a therapeutic focus on cancer. John holds a Ph.D. from the University of London, Institute of Cancer Research.
“I believe that both nimotuzumab and AeroLEF™ represent compelling opportunities for YM BioSciences, each having the potential to significantly improve patient care in its respective indication,” said John Waterfall. “As such, I look forward to formalizing the project management system within YM BioSciences that will facilitate the rapid approval of these important drugs.”
Dianne Harris has substantial experience in the development of drugs, medical devices and drug-device combinations to treat both chronic and acute pain indications. Until 2003, she held the position of General Manager at Elan Medical Technologies where she was responsible for the design of R&D programs to achieve commercial milestones and progressed 16 new therapies into clinical evaluation. Her 20 years of experience includes program management across several therapeutic areas from her work at Glaxo and Wyeth as well as Elan.