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

Cyclacel Pharmaceuticals, Inc. (Nasdaq: 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."