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Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Advanced Multiple Myeloma
Date:12/16/2009

ed, "We would like to thank Dr. Richardson, Dr. Anderson and the other clinical investigators involved for their dedication to the perifosine multiple myeloma development program."

Dr. Richardson stated, "Despite recent advances, multiple myeloma remains a devastating and challenging disease for which we believe combination treatment will be beneficial to the majority of patients. We are very encouraged by the perifosine + bortezomib combination in regards to overall response rate, progression-free survival and overall survival data observed to date. If the results from this Phase 3 study prove positive, we believe that this orally administered novel agent could make an important difference for patients with advanced multiple myeloma."

Dr. Ken Anderson commented, "We are very excited to be leading this pivotal program alongside our multiple myeloma colleagues nationwide. Based on the synergies observed in preclinical models, and most importantly, the clinical data generated in the Phase 1/2 study, we believe the combination of perifosine with bortezomib can significantly improve patient outcomes in this disease."

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico. In addition to multiple myeloma, other clinical development efforts with perifosine are focused in the areas of colorectal cancer, renal cell carcinoma and other tumor types.

About the Phase 3 Trial Design

The Phase 3 trial is a randomized (1:1), double-blind trial comparing the efficacy and safety of KRX-0401 (perifosine) to placebo when combined with bortezomib and dexamethasone in approximately 400 patients with relapsed or relapsed / refractory multiple myeloma. Patients will be randomized to bortezomib at 1.3 mg/m2 days 1, 4, 8 and 11 every 21 days in combination with dexamethasone 20 mg on the day of and day after bortezomib treatment, and either perifosine 50 mg daily or placebo
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SOURCE Keryx Biopharmaceuticals, Inc.
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