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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

omib and dexamethasone in heavily pre-treated patients with relapsed and refractory disease. Given this positive data and our favorable experience overall with perifosine in this setting, we are hopeful that the upcoming Phase 3 trial will demonstrate clinical benefit for our patients with less advanced myeloma."

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We'd like to thank the FDA and Drs. Paul Richardson and Ken Anderson for their substantial input and guidance during this process. Achievement of this KRX-0401 SPA is a major developmental milestone for Keryx." Mr. Bentsur continued, "We are excited to be moving forward with this very promising compound which we believe is the most advanced PI3K/Akt pathway inhibitor in clinical development."

Phase 3 Design

The Phase 3 trial is a randomized (1:1), double-blind trial comparing the efficacy and safety of KRX-0401 to placebo when combined with bortezomib and dexamethasone in approximately 400 patients with relapsed or relapsed / refractory multiple myeloma. Patients must have been previously treated with both bortezomib (VELCADE((R))) and an immunomodulatory agent (REVLIMID((R)) or THALIDOMID((R))), and been previously treated with one to four prior lines of therapy. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety.

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.

About Multiple Myeloma

Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,50
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SOURCE Keryx Biopharmaceuticals, Inc.
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