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Journal of Clinical Oncology Publishes Phase 2 Clinical Trial Results of KRX-0401 (Perifosine) Plus Capecitabine in Patients with Metastatic Colorectal Cancer
Date:10/5/2011

NEW YORK, Oct. 5, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) (the "Company") today announced that a manuscript entitled "Randomized Placebo-Controlled Phase II Trial of Perifosine Plus Capecitabine as Second- or Third-Line Therapy in Patients with Metastatic Colorectal Cancer" reporting Phase 2 activity of KRX-0401 (perifosine) in the treatment of patients with refractory, advanced colorectal cancer (mCRC), was selected for publication in the October 3, 2011 online edition of the Journal of Clinical Oncology (JCO).  Perifosine, the Company's novel, potentially first-in-class, oral anti-cancer drug candidate that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, is currently being investigated in a Phase 3 trial entitled the "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment),which is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine. The Phase 3 X-PECT study is being conducted under a Special Protocol Assessment (SPA), and with Fast Track designation.  In July, the Company announced the completion of enrollment into the Phase 3 X-PECT study, with approximately 465 patients in the United States randomized. Approximately 360 events of death will trigger the un-blinding of the study.  Study completion is expected in 1Q 2012.

The JCO publication highlights the efficacy and safety data on the 38 mCRC patients participating in this Phase 2, randomized, multicenter study, comparing perifosine plus capecitabine (P-CAP) to placebo plus capecitabine.  Based on the data, in which the combination of P-CAP demonstrated statistical significance with respect to median overall survival and median time to tumor progression, the investigators concluded that the P-CAP combination showed promising clinical activity co
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SOURCE Keryx Biopharmaceuticals, Inc.
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