March 18, 2008 (PRIME NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to milatuzumab for the treatment of multiple myeloma.
The designation allows the Company to have a seven-year market exclusivity for milatuzumab in multiple myeloma upon final approval by the FDA. Other financial benefits and incentives include waiver of Prescription Drug User Fee Act (PDUFA) filing fees, tax credits for the costs of clinical research, and assistance in clinical research study designs.
"We are pleased to receive Orphan Drug designation for milatuzumab. Preclinical studies by us and other scientists have shown that milatuzumab inhibits the growth of human multiple myeloma and lymphoma cells in culture and in mouse models, and blocks the over-expression of CD74 in chronic lymphocytic leukemia cells, which leads to increased cell death. We have initiated Phase I/II studies to evaluate the therapeutic potential of milatuzumab in patients with multiple myeloma, non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL)," commented Cynthia L. Sullivan, President and CEO.
In addition, John P Leonard, MD, Professor of Medicine at Weill Medical College of Cornell University, is conducting a Phase I study in patients with recurrent NHL or CLL funded in part by a grant from the National Cancer Institute.
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