SOUTH SAN FRANCISCO, Calif., April 2, 2008 /PRNewswire/ -- Proteolix, Inc., a clinical-stage company engaged in the development of novel pharmaceutical therapies for the treatment of cancer and immunological conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to carfilzomib, a selective blocker of proteasome activity for the treatment of multiple myeloma. The orphan drug designation encompasses all subsets of multiple myeloma and Waldenstrom's macroglobulinemia.
"I am very pleased by our receipt of this designation for carfilzomib," said Susan Molineaux, Ph.D., the Company's President and CEO. "To date we have been encouraged by carfilzomib's early-stage clinical results in multiple myeloma, and we continue to believe it has the potential to offer cancer patients a new and effective treatment for their disease."
The Orphan Drug Act of 1983 allows the FDA to grant orphan drug status to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. According to the SEER Database of the National Cancer Institute (2004), the U.S. prevalence of multiple myeloma was 53,712 patients. The Orphan Drug Act provides the drug developer with several financial benefits and incentives related to the orphan drug, including tax credits for clinical research costs, ability to apply for annual grant funding, clinical research trial design assistance, waiver of Prescription Drug User Fee Act (PDUFA) filing fees, and a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication.
About Multiple Myeloma
Multiple myeloma is cancer of the plasma cell. It begins in the bone
marrow, where blood cells are made. The plasma cell is a type of white
blood cell that fights infections by making antibodies. Cancerous plasma
cells, also called myeloma cells, divide and grow out of control, build
|SOURCE Proteolix, Inc.|
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