Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML). Sunesis is currently conducting two Phase 2 clinical trials of voreloxin in AML: a single-agent study, known as REVEAL-1, of voreloxin in newly diagnosed elderly AML patients unlikely to benefit from standard induction chemotherapy and a study evaluating voreloxin in combination with cytarabine in relapsed/refractory AML.
"This designation recognizes the acute need for more options in treating this poor-prognosis disease," stated Steven B. Ketchum, Ph.D., Senior Vice President of Research and Development at Sunesis. "We believe voreloxin has the potential to impact the standard of care for AML and we continue to be encouraged by our progress. We are finalizing a registration strategy for voreloxin in AML and anticipate launching a pivotal trial in 2010."
Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval and an exemption from user fees.
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