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Aeterna Zentaris: Journal of Clinical Oncology Publishes Phase 2 Clinical Trial Results of Perifosine Plus Capecitabine in Patients with Metastatic Colorectal Cancer
Ongoing Phase 3 trial under Special Protocol Assessment and with Fast Track designation is fu...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\n\n\nOngoing Phase 3 trial under Special Protocol Assessment and with Fast\n Track designation is fully enrolled\n\n\nQUÉBEC CITY, Oct. 5, 2011 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\"), today announced that a manuscript\n entitled, \"Randomized Placebo-Controlled Phase 2 Trial of Perifosine Plus\n Capecitabine as Second- or Third-Line Therapy in Patients with\n Metastatic Colorectal Cancer \" reporting Phase 2 activity of perifosine (KRX-0401) in the treatment\n of patients with refractory, advanced colorectal cancer (mCRC), was\n selected for publication in the October 3, 2011 online edition of the\n Journal of Clinical Oncology (JCO). Perifosine, the Company's Akt/PI3K\n inhibitor, is currently being investigated in a Phase 3 trial entitled\n the \"X-PECT\" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment), which is a randomized (1:1), double-blind trial comparing the\n efficacy and safety of perifosine + capecitabine vs. placebo +\n capecitabine. In July, the Company announced the completion of\n enrolment of the Phase 3 X-PECT study, with approximately 465 patients\n in the United States randomized. Approximately 360 events of death will\n trigger the un-blinding of the study. Study completion is expected in\n Q1 2012.\n\n\nThe JCO publication highlights the efficacy and safety data on the 38\n mCRC patients participating in this Phase 2, randomized, multicenter\n study, comparing perifosine plus capecitabine (P-CAP) to placebo plus\n capecitabine. Based on the data, in which the combination of P-CAP\n demonstrated statistical significance with respect to median overall\n survival and median time to tumor progression, the investigators\n concluded that the P-CAP combination showed promising clinical activity\n compared to single-agent capecitabine, and that the difference in\n clinical outcome seen with the addition of perifosine was impressive.\n\n\nEfficacy data from this study was previously presented in June 2010 at\n the 46th Annual Meeting of the American Society of Clinical Oncology.\n\n\nA copy of the article featured in the current online edition of the\n Journal of Clinical Oncology can be obtained at http://jco.ascopubs.org/content/early/2011/10/03/JCO.2011.36.1980.abstract.\n\n\nAbout Perifosine\n\n\nPerifosine is a novel, oral an...