Phase 3 study of perifosine for metastatic colon cancer

Æterna Zentaris and Keryx Biopharmaceuticals announced agreement with the FDA regarding a Special Protocol Assessment on its Phase 3 trial for perifosine (KRX-0401) for the treatment of refractory metastatic colorectal cancer.  The Phase 3 X-PECT (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) trial will be a randomized, double-blind trial comparing the efficacy and safety of perifosine + capecitabine (Xeloda, from Roche) versus placebo + capecitabine in approximately 430 patients with refractory metastatic colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin, from sanofi-aventis), irinotecan (Camptosar, from Pfizer), bevacizumab (Avastin, from Genentech) and, if K-Ras wild-type (WT), failed therapy with prior cetuximab (Erbitux, from Bristol-Myers Squibb) or panitumumab (Vectibix, from Amgen).

Perifosine is a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival.

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