The Company recently held a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss a randomized Phase 3 study design for Cyclacel's oral sapacitabine capsules in acute myeloid leukemia (AML) and separately in myelodysplastic syndromes (MDS).
Sapacitabine capsules (CYC682), an orally available nucleoside analogue, is currently being evaluated in Phase 2 trials in hematological and solid tumors. Sapacitabine acts through a dual mechanism, interfering with DNA synthesis by causing single-strand DNA breaks and inducing arrest of cell cycle progression mainly at G2/M-Phase. Both sapacitabine and CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in preclinical studies.
Link:http://www.cyclacel.com/cyc/investors/news/pressreleases/2009/2009-12-15/
Source:Cyclacel