December 02, 2009
FDA fast track designation granted for KRX-0401 (perifosine) for relapsed/refractory multiple myelomaKeryx 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.
For more information call (212) 531-5965 or visit www.keryx.com.