Aeterna Zentaris Announces Completion of Interim Analysis by Data Safety Monitoring Board for the Phase 3 Study of Perifosine for the Treatment of Refractory Advanced Colorectal Cancer

Aeterna Zentaris Inc. AEZS today announced that the independent Data Safety Monitoring Board for the pivotal Phase 3 X-PECT study of perifosine in patients with refractory advanced colorectal cancer has completed a pre-specified interim analysis for safety and futility. The DSMB has recommended that the Phase 3 study continue to completion, as planned. This Phase 3 study sponsored and conducted by our North American licensee for perifosine, Keryx Biopharmaceuticals, Inc., (Keryx), KERX, has completed enrollment, with over 465 patients from 65 U.S. sites. The study is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration and with Fast-Track Designation. Furthermore, the Company has received positive Scientific Advice from the European Medicines Agency for this ongoing Phase 3 trial, which is therefore expected to be sufficient for registration in Europe. Perifosine rights have also been licensed to Yakult Honsha for Japan and to Handok for Korea.