Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) 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.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
A randomized, double-blind Phase 3 trial investigating perifosine in combination with capecitabine (Xeloda®) 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.
Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "We believe that this Fast Track designation adds substantial value to perifosine's development in refractory advanced colorectal cancer. We intend to initiate the Phase 3 colorectal study in the second quarter, with study completion expected in the second half of 2011. With the SPA and Fast Track designation in place, we believe that commercialization of perifosine in this indication could potentially commence by mid-2012."
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.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS; TSX: AEZ) in the United States, Canada and Mexico.
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