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Article: Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma.
- Article from:
- PR Newswire
- Article date:
- September 16, 2009
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Phase 3 registration trial under SPA expected to start by year-end
NEW YORK, Sept. 16 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. today announced that KRX-0401 (perifosine) has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, the Company announced that it had reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "The Orphan-Drug designation for perifosine in ...