Aeterna Zentaris (AEZS) Reports Independent DSMB Completes Pre-Specified Interim Analysis of Perifosine Phase 3 X-PECT (KERX)
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Aeterna Zentaris, Inc. (Nasdaq: AEZS), reports that the independent Data Safety Monitoring Board (DSMB) 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), (Nasdaq: 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 (FDA) and with Fast-Track Designation. Furthermore, the Company has received positive Scientific Advice from the European Medicines Agency (EMA) 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.
The Phase 3 trial, entitled the "X-PECT" (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) trial, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in over 465 randomized patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin), irinotecan, bevacizumab (Avastin) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux) and/or panitumumab (Vectibix). The primary endpoint is overall survival, with secondary endpoints including overall response rate (complete + partial responses), progression-free survival and safety. Approximately 360 events of death will trigger the unblinding of the study.
This Phase 3 study sponsored and conducted by our North American licensee for perifosine, Keryx Biopharmaceuticals, Inc., (Keryx), (Nasdaq: 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 (FDA) and with Fast-Track Designation. Furthermore, the Company has received positive Scientific Advice from the European Medicines Agency (EMA) 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.
The Phase 3 trial, entitled the "X-PECT" (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) trial, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in over 465 randomized patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin), irinotecan, bevacizumab (Avastin) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux) and/or panitumumab (Vectibix). The primary endpoint is overall survival, with secondary endpoints including overall response rate (complete + partial responses), progression-free survival and safety. Approximately 360 events of death will trigger the unblinding of the study.
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