Keryx Biopharmaceuticals Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer
NEW YORK, April 5 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.
A randomized, double-blind Phase 3 trial investigating perifosine in combination with capecitabine (Xeloda(R)) versus placebo in combination with capecitabine in patients with refractory advanced colorectal cancer is expected to commence in the second quarter of 2010 under a Special Protocol Assessment (SPA) with the FDA.
In addition to colorectal cancer, perifosine is currently in a Phase 3 trial, under SPA, for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track designation granted.
About KRX-0401 (perifosine)
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