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Cyclacel's Sapacitabine Nearly Doubles Expected Survival Of Elderly Patients With MDS After Front-Line Therapy Failure

At ASCO 2012 Cyclacel reported interim data from three schedules of sapacitabine administered as single-agent treatment over a 4-week cycle in 63 patients with IPSS intermediate-1 or higher risk MDS after treatment failure of hypomethylating agents: 200 mg twice daily for 7 days as Arm G, 300 mg once daily for 7 days as Arm H, or 100 mg once daily for 5 days per week for 2 weeks as Arm I.  Median overall survival was 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. Median overall survival for all three arms is 252 days (approx. 8 months). In terms of secondary efficacy endpoints complete remissions (CRs) and major hematologic improvement (HI) in platelet counts or neutrophils, were observed on all 3 dosing schedules: 1 CR and 3 HIs in Arm G, 1 CR and 2 HIs in Arm H, and 2 CRs and 1 HI in Arm I. The 30-day mortality from all causes is 5%.   Forty-one percent of all patients received 4 or more cycles. At the time of ASCO 2012 more than 34% of the patients were still alive and longer follow-up is needed to assess 1-year survival and overall survival.

At ASH 2010 Cyclacel reported interim data from three schedules of sapacitabine administered as single-agent treatment over a 4-week cycle in 61 patients with IPSS intermediate-1 or higher risk MDS after treatment failure of hypomethylating agents: 200 mg twice daily for 7 days as Arm A, 300 mg twice daily for 7 days as Arm B, or 400 mg twice daily for 3 days per week for 2 weeks as Arm C. The primary endpoint of 1-year survival was achieved in 29%, 30% and 35% of the patients respectively among the 3 schedules tested. Median overall survival was 217 days (approx. 7 months), 232 days (approx. 8 months) and 236 days (approx. 8 months) respectively. Two patients achieved a CR and 13 achieved major hematologic improvement. The 30-day mortality from all causes was 6.6%.

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