Atlanta, GA 6/29/12 (StreetBeat) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) today announced that its Japanese partner Yakult Honsha ("Yakult") has initiated a Phase 1 trial in multiple myeloma, a form of blood cancer, with perifosine, the Company's oral Akt/PI3K inhibitor drug. Yakult, who are sponsoring and conducting this trial in Japan , reported that a first patient has been treated with perifosine.
This is an open-label, two step Phase 1 trial in which perifosine is combined with bortezomib (Velcade®) and dexamethasone in patients with refractory multiple myeloma who had previously been treated with bortezomib. The trial is expected to include a total of 18 patients (6 in step 1 and 12 in step 2). Patients will receive perifosine daily (50 mg, Days 1-21) in combination with bortezomib (1.3 mg/m2, Days 1, 4, 8 and 11) and dexamethasone (20 mg, Days 1, 2, 4, 5, 8, 9, 11 and 12) according to a three-week cycle (21 days ± 3 days). The primary endpoint is safety while secondary endpoints include response rate, progression-free survival, and time to tumor progression.
Juergen Engel, PhD, President and CEO at Aeterna Zentaris stated, "We would like to thank our partner Yakult for their close collaboration in initiating this important Phase 1 trial in multiple myeloma which is necessary at this time in order to comply with Japan's specific registration requirements. Perifosine, also currently in a Phase 3 trial in other parts of the world in multiple myeloma for which we expect to reach an interim analysis in the first quarter of next year, remains a key component of our deep pipeline focused on providing novel, targeted treatment options for cancer patients facing unmet medical needs".
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