Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Multip... ( NEW YORK Aug. 3 /- Keryx ...)

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Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Multiple Myeloma

Date:8/3/2009

NEW YORK, Aug. 3 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in relapsed or relapsed / refractory multiple myeloma patients previously treated with bortezomib (VELCADE((R))). The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission. The trial, entitled, "A Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib" will be a double-blind, placebo-controlled trial comparing the efficacy and safety of KRX-0401 vs. placebo when combined with bortezomib and dexamethasone. The trial, powered at 90%, will enroll approximately 400 patients with relapsed or relapsed / refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety.

Dr. Kenneth Anderson, Chief, Division of Hematologic Neoplasia, Dana-Farber Cancer Institute, commented, "Perifosine holds great promise for multiple myeloma patients worldwide. We at Dana-Farber, along with our other collaborating multiple myeloma centers, are encouraged to see perifosine move into this final stage of testing, and look forward to working with Keryx on this exciting trial."

Dr. Paul Richardson, Clinical Director of the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute and Study Chairman for the KRX-0401 Phase 3 trial, added, "Perifosine has shown considerable activity when combined with bortez
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SOURCE Keryx Biopharmaceuticals, Inc.
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