Aeterna Zentaris: Phase 3 Data for Perifosine in Colorectal Cancer Presented at ASCO Meeting

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[{"type":"text","content":"\n\n\n\n\n\nQUÉBEC CITY, June 4, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that Johanna Bendell,\n MD, Director of Gastrointestinal Cancer Research and Associate Director\n of Drug Development at the Sarah Cannon Research Institute in\n Nashville, Tennessee, presented Phase 3 results for perifosine in\n refractory colorectal cancer yesterday, at the American Society of\n Clinical Oncology (ASCO) Annual Meeting which is being held in Chicago.\n Dr. Bendell was the lead investigator of the trial. Data showed no\n benefit in overall survival when adding perifosine to capecitabine in\n the refractory colorectal cancer setting, confirming top line results\n previously disclosed by the Company on April 2, 2012.\n\n\nThe Study\n\n\nThis was a randomized (1:1), double-blind Phase 3 trial conducted in the\n United States by our former licensee Keryx Biopharmaceuticals,\n comparing the efficacy and safety of capecitabine + perifosine (P-CAP)\n vs capecitabine + placebo (CAP), involving 468 patients with metastatic\n colorectal cancer which was refractory to all standard therapies.\n Primary endpoint was overall survival (OS) with secondary endpoints\n including overall response-rate (ORR) (complete (CR) + partial\n responses (PR)), progression-free survival (PFS) and safety\n (clinicaltrials.gov NCT 01002248).\n\n\nResults\n\n\nFor the total intent to treat (ITT) patient population, median OS was\n 6.9 months for the CAP group compared to 6.4 months for the P-CAP\n group. Median PFS was 11.4 months for the CAP group compared to 10.9\n months for the P-CAP group. The differences were not statistically\n significant. There were 7 complete and partial responses in the CAP\n group compared to 6 complete and partial responses in the P-CAP group.\n\n\nThere was no significant difference in toxicity profiles between the two\n arms. The most frequent hematologic adverse event was grade 1/2 anemia\n (CAP = 30 vs P-CAP = 49). The most non-hematologic adverse event was\n grade 1/2 fatigue (CAP = 95 vs P-CAP = 125).\n\n\nIn one pre-defined subgroup to which patients were stratified, those who\n expressed the wild-type K-ras proto-oncogene and who had discontinued\n oxaliplatin for toxicity rather than for disease progression, there was\n a benefit in OS (...

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