Cyclacel Provides Update on Clinical Progress With Sapacitabine as Second Line Therapy in Older Patients With Myelodysplastic Syndromes

Cyclacel Pharmaceuticals, Inc. CYCC announced today new topline response data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules, a novel nucleoside analogue, in older patients with myelodysplastic syndromes after treatment failure of hypomethylating agents, such as azacitidine and/or decitabine. Eight patients responded with 2 complete remissions, 2 complete remissions with incomplete platelet count recovery and 4 major hematological improvements of platelet counts or neutrophils. More than 50% of the patients are still alive and longer follow-up is needed to assess 1-year survival and overall survival. "MDS patients have poor outcome after treatment failures of front-line hypomethylating agents. The interim response data indicates that sapacitabine is active in this patient population," said Hagop Kantarjian, M.D., Chairman & Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and principal investigator for the study. "Front line treatment of MDS with hypomethylating agents results in a CR rate ranging from 5.6% to 17%. It is encouraging to observe CRs in MDS patients treated with sapacitabine as a single agent after failures of hypomethylating agents."