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Aeterna Zentaris: Partner Yakult Initiates Phase 1 Trial in Multiple Myeloma with Perifosine in Japan
QUEBEC CITY, June 28, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX:&#...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\n\n\nQUEBEC CITY, June 28, 2012 /CNW Telbec/ - Aeterna Zentaris Inc.\n (NASDAQ: AEZS) (TSX: AEZ) (the \"Company\") today announced that its\n Japanese partner Yakult Honsha (\"Yakult\") (Tokyo: 2267) has initiated a\n Phase 1 trial in multiple myeloma, a form of blood cancer, with\n perifosine, the Company's oral Akt/PI3K inhibitor drug. Yakult, who are\n sponsoring and conducting this trial in Japan, reported that a first\n patient has been treated with perifosine.\n\n\nThis is an open-label, two step Phase 1 trial in which perifosine is\n combined with bortezomib (Velcade®) and dexamethasone in patients with refractory multiple myeloma who had\n previously been treated with bortezomib. The trial is expected to\n include a total of 18 patients (6 in step 1 and 12 in step 2). Patients\n will receive perifosine daily (50 mg, Days 1-21) in combination with\n bortezomib (1.3 mg/m2, Days 1, 4, 8 and 11) and dexamethasone (20 mg, Days 1, 2, 4, 5, 8, 9,\n 11 and 12) according to a three-week cycle (21 days ± 3 days). The\n primary endpoint is safety while secondary endpoints include response\n rate, progression-free survival, and time to tumor progression.\n\n\nJuergen Engel, PhD, President and CEO at Aeterna Zentaris stated, \"We\n would like to thank our partner Yakult for their close collaboration in\n initiating this important Phase 1 trial in multiple myeloma which is\n necessary at this time in order to comply with Japan's specific\n registration requirements. Perifosine, also currently in a Phase 3\n trial in other parts of the world in multiple myeloma for which we\n expect to reach an interim analysis in the first quarter of next year,\n remains a key component of our deep pipeline focused on providing\n novel, targeted treatment options for cancer patients facing unmet\n medical needs\".\n\n\nAbout Perifosine\n\n\nPerifosine is a novel, oral anticancer treatment that inhibits Akt\n activation in the phosphoinositide 3-kinase (PI3K) pathway. It has been\n granted orphan drug and orphan medicinal product designations from both\n the FDA and EMA for multiple myeloma. Perifosine has also received Fast\n Track designation from the FDA and positive Scientific Advice from the\n EMA with results from the Phase 3 trial in multiple myeloma expected to\n be sufficient for registration in Europe, as ...