subject: Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) Cancer Drug Gets FDA Orphan Status [print this page] Cyclacel Pharmaceuticals, IncCyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) Cancer Drug Gets FDA Orphan Status
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC)has been developing a product called sapacitabine (CYC682) for the treatment of both acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). This cell cycle modulating nucleoside analogue is currently in Phase 2 studies for the treatment of AML in the elderly, MDS, and lung cancer. Cyclacel plans to advance sapacitabine into pivotal Phase 3 development n 2010. During the 1st quarter of 2010, the company submitted a Special Protocol Assessment (SPA) request to the FDA for a randomized Phase 3 study of the drug in elderly patients with AML.
Today, Cyclacel announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's sapacitabine product candidate for the treatment of both AML and MDS. This orphan drug designation entitles Cyclacel Pharmaceuticals to 7 years of marketing exclusivity for sapacitabine upon regulatory approval. Other benefits include the opportunity to apply for grant funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses, and a potential waiver of the FDA's application user fee. Orphan status is granted by the FDA to promote the development of new drug therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States.
"Orphan drug designation for both AML and MDS significantly strengthens the value proposition represented by sapacitabine and enhances our opportunity to advance this promising product candidate to late stage clinical development and commercialization," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel.
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