AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multip...( QUEBEC CITY Aug. 3 / AEterna Zentaris...)

QUEBEC CITY, Aug. 3 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), ("the Company") a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), its partner and licensee for perifosine in the North American market, has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), in relapsed or relapsed/refractory multiple myeloma patients previously treated with bortezomib (VELCADE(R)). The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission. The study, entitled, "A Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib", will be a double-blind, placebo-controlled study comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib and dexamethasone. The trial, powered at 90%, 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.

Juergen Engel, Ph. D., President and Chief Executive Officer of AEterna Zentaris commented, "We are very pleased and excited about perifosine moving forward into a Phase 3 trial. This represents a major milestone in our oncology drug development strategy which could hold great promise for patients with multiple myeloma."

About the Phase 3 Trial De
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