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发帖数: 4754 | 1 Keryx 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. (
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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