Trial conducted pursuant to Special Protocol Assessment with the Food and Drug Administration
QUEBEC CITY, Dec. 16 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company"), a global biopharmaceutical company focused on oncology and endocrine therapy, today announced the initiation, by its partner Keryx Biopharmaceuticals Inc. ("Keryx") ( KERX), of a Phase 3 registration clinical trial for perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in relapsed/refractory multiple myeloma patients. Keryx is AEterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while AEterna Zentaris retains rights for the rest of the world.
The trial, entitled, "A Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib (Velcade(R)) and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib", is a double-blind, placebo-controlled trial comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib (Velcade(R)) and dexamethasone. The trial will enroll approximately 400 patients with relapsed or relapsed/refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). Additionally, the FDA has granted perifosine Orphan Drug and Fast Track designations in this indication. An estimated 40 to 50 centers throughout the United States and select centers outside of the United States will be participating in this Phase 3 trial.
The Phase 3 trial is being led by the Principal Investigator
|SOURCE AETERNA ZENTARIS INC.|
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