Jun. 29, 2010 (Canada NewsWire Group) --
Of the 38 patients enrolled in the Phase 2 study, 27 patients were previously refractory to a 5-FU based regimen. A Phase 3 randomized double-blind trial comparing perifosine + capecitabine vs. placebo + capecitabine in 5-FU refractory patients with advanced refractory colorectal cancer (X-PECT trial), under Special Protocol Assessment (SPA) from the Food and Drug Administration (FDA), is currently open and enrolling patients at multiple centers throughout the U.S. This Phase 3 trial is sponsored by Keryx Biopharmaceuticals, Inc. ("Keryx") (Nasdaq: KERX), Aeterna Zentaris' licensee for perifosine in the
Perifosine, a novel, potentially first-in-class, oral Akt inhibitor, is currently in Phase 3 trials for advanced colorectal cancer and multiple myeloma, under SPA and Fast Track designation granted by the FDA for both indications. Perifosine has also been granted orphan-drug status by the FDA for multiple myeloma and has received a positive opinion for Orphan Medicinal Product designation from the European Medicines Agency (EMA) in this same indication. In addition, perifosine has received positive Scientific Advice from the EMA for both multiple myeloma and colorectal cancer programs.
Perifosine is also in a Phase 1 trial in pediatric patients, as well as in other Phase 1 and Phase 2 trials for several other tumor types.
Perifosine is licensed to Keryx, in the
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. News releases and additional information are available at www.aezsinc.com.
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