Cyclacel Pharmaceuticals, Inc. announced new data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules in older patients with myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents, such as azacitidine or decitabine.
Median overall survival to date for all patients is 252 days or approximately 8.4 months. Data were presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting.
The open-label, multi-center, Phase 2 study randomized 63 patients aged 60 years or older with MDS of intermediate-2 or high-risk classification by the International Prognostic Scoring System (IPSS) at study entry to receive sapacitabine every 4 weeks on one of the 3 dosing schedules: 200 mg twice daily for 7 days (Arm G), 300 mg once daily for 7 days (Arm H), or 100 mg once daily for 5 days per week for 2 weeks (Arm I).
The primary efficacy endpoint of the study is 1-year survival with the objective of identifying a dosing schedule that produces a better 1-year survival rate in the event that all three dosing schedules are active. All patients in the study progressed after receiving azacitidine, decitabine, or both agents.
The median overall survival for each arm was reported as follows: 240 days for Arm G; 290 days for Arm H; and 153 days for Arm I. The median overall survival for all three arms is 252 days. 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. The 30-day mortality from all causes is 5%.
Release Date: June 1, 2012
Source: Cyclacel Pharmaceuticals
Filed Under: Drug Discovery