Keryx Biopharmaceuticals announced that the FDA has granted fast track designation to KRX-0401 (perifosine) for the treatment of relapsed/refractory multiple myeloma. A Phase 3 trial investigating perifosine in combination with Velcade (bortezomib) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. Previously, Keryx announced that perifosine had received Orphan-Drug designation in the U.S. for the treatment of multiple myeloma.

Perifosine is a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. Perifosine also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival.

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