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Keryx Biopharmaceuticals Announces Completion of Patient Enrollment in KRX-0401 (Perifosine) Phase 3 Refractory Advanced Colorectal Cancer Study
Date:7/27/2011

NEW YORK, July 27, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced completion of patient enrollment in its Phase 3 registration trial of KRX-0401 (perifosine) for the treatment of refractory, advanced colorectal cancer.  This Phase 3 trial, with over 430 randomized patients, is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA) and with Fast-Track Designation.  Perifosine is a novel, potentially first-in-class, oral anti-cancer drug candidate that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway.

The Phase 3 trial, entitled the "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) trial, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in over 430 patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin®), irinotecan, bevacizumab (Avastin®) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux®) and/or panitumumab (Vectibix®).  The primary endpoint is overall survival, with secondary endpoints including overall response rate (complete + partial responses), progression-free survival and safety.  Approximately 360 events of death will trigger the un-blinding of the study.

Dr. Johanna Bendell, Director of GI Oncology Research for the Sarah Cannon Research Institute, Nashville, Tennessee, is Study Chair for the Phase 3 investigational team. Dr. Cathy Eng, Associate Medical Director for the Colorectal Center at MD Anderson Cancer Center in Houston, Texas, is the Lab Correlative Study Chair l
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