Cyclacel Pharmaceuticals, Inc. (CYCC, CYCCP) announced new data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules, the Company's lead product candidate, in older patients with myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents, such as azacitidine (Vidaza) and/or decitabine (Dacogen).
Median overall survival to date for all patients is 252 days or approximately 8.4 months. Data were presented as a poster during the 2012 American Society of Clinical Oncology or ASCO Annual Meeting being held June 1-5, 2012, in Chicago, Illinois.
At ASCO, the median overall survival for each arm was reported as follows: 240 days (approx. 8 months) for Arm G, 290 days (approx. 10 months) for Arm H, and 153 days (approx. 5 months) for Arm I. The median overall survival for all three arms is 252 days (approx. 8 months).
The company said that complete remissions (CRs) and major hematologic improvement (HI) in platelet counts or neutrophils, secondary efficacy endpoints in the study, were observed on all 3 dosing schedules as follows: 1 CR and 3 HI's in Arm G, 1 CR and 2 HI's in Arm H, and 2 CRs and 1 HI in Arm I. The thirty-day mortality from all causes is 5%. Forty-one percent of all patients received 4 or more cycles. More than 34% of the patients are still alive and longer follow-up is needed to assess 1-year survival and overall survival.
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