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.
For more information call (212) 531-5965 or visit www.keryx.com.