Cyclacel Posts MDS Trial Results

Cyclacel Pharmaceuticals has posted new, primary endpoint data from an ongoing, open-label, multicenter, randomized Phase II 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 and/or decitabine.

 

The seven-day dose regimen of 200 mg twice daily (Arm G), appears to be a better schedule with a one-year survival rate of 38%, median overall survival of approximately 10 months and response rate of 19%. The 30-day mortality from all causes for all patients is 5%. Data were presented at a poster-session during the 2013 American Society of Hematology (ASH) Meeting and Exposition held in New Orleans, LA.

 

The company is enrolling patients in its pivotal Phase III study of sapacitabine in elderly patients with acute myeloid leukemia (AML).

 

The open-label, multi-center, Phase II study randomized 63 patients aged 60 years or older with MDS of intermediate-2 (n=52) or high-risk (n=11) classification by the International Prognostic Scoring System (IPSS) at study entry to receive sapacitabine every four weeks on one of three 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 two weeks (Arm I). 

 

The primary efficacy endpoint is one-year survival with the objective of identifying a dosing schedule that produces a better one-year survival rate in the event that all three dosing schedules are active. Median age was 73. Forty-one patients had 10-19% blasts in their bone marrow. All patients in the study progressed after receiving either azacitidine and/or decitabine. Eighteen patients were double refractory as they had received both agents.