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news.Cyclacel Pharmaceuticals has received FDA's orphan drug status to Sapacitabine (CYC682) product candidate for the treatment of both acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
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Sapacitabine is an oral nucleoside analog prodrug that acts through a dual mechanism. The compound interferes with DNA synthesis by causing single-strand DNA breaks and induces arrest of the cell division cycle at G2 phase.
Cyclacel has reported Phase 2 results from ongoing studies in AML and MDS. The company plans to advance Sapacitabine into pivotal Phase 3 development in 2010.
During the first quarter of 2010, Cyclacel has submitted a special protocol assessment (SPA) request to the FDA for a randomised Phase 3 study of Sapacitabine in elderly patients with AML.
Spiro Rombotis, president and CEO of Cyclacel, said: “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 commercialisation.”