Æterna Zentaris and Keryx Biopharmaceuticals announced that Fast Track designation was granted by the FDA for perifosine (KRX-0401) for the treatment of refractory advanced colorectal cancer. A randomized, double-blind Phase 3 trial investigating perifosine in combination with Xeloda (capecitabine) versus placebo in combination with Xeloda in patients with refractory metastatic colorectal cancer is expected to commence this quarter under a Special Protocol Assessment (SPA) with the FDA.
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. Perifosine 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.