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Keryx Says Perifosine X-PECT Phase 3 Trial Failed To Meet Primary Goal

Keryx Biopharmaceuticals, Inc. (KERX) said the Phase 3 "X-PECT", or Xeloda + Perifosine Evaluation in Colorectal cancer Treatment, clinical trial evaluating perifosine (KRX-0401) + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer failed to achieve the primary endpoint of improving overall survival versus capecitabine + placebo.

The company noted that 468 patients at sixty-five U.S. sites participated in the study.

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We are all extremely disappointed with the results of the study...We will evaluate whether our Phase 3 study of Perifosine in relapsed/refractory multiple myeloma will continue as planned.

With approximately $31 million in cash as of March 31, 2012, and a well-controlled burn rate, we plan to focus our resources on the pending completion of the Zerenex (ferric citrate) long-term Phase 3 study for end stage renal disease (ESRD) patients with hyperphosphatemia, expected in the fourth quarter of 2012, and the New Drug Application (NDA) filing for Zerenex which will hopefully follow shortly thereafter."

by RTT Staff Writer

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