Cyclacel Reports Updated Phase 2 Survival Data Of Sapacitabine For MDS

BERKELEY HEIGHTS, N.J., April 30, 2013 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company), announced updated median overall survival data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules, the Company's lead product candidate, in older patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents, such as azacitidine (Vidaza®) and/or decitabine (Dacogen®). Median overall survival to date for all 63 patients treated is approximately 9 months. Median overall survival for each of the three randomization schedules is approximately 10 months for Arm G, 10 months for Arm H and 8 months for Arm I. The 30-day mortality for all patients is 5%.

"The updated survival data from this study in MDS patients after treatment failures of hypomethylating agents continue to be impressive based on our experience," said Guillermo Garcia-Manero, M.D., Chief of the Section of Myelodysplastic Syndromes and Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and an investigator for the study. "Sapacitabine's oral administration and low 30-day mortality suggest that it may become a new treatment standard for older patients with MDS."

"There is a dearth of treatment options for MDS patients after failing front-line therapies. The updated survival data with sapacitabine as a single agent in MDS confirm our previous experience with the drug," said Hagop Kantarjian, M.D., Chairman & Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and principal investigator for the study. "Median survival for patients with intermediate-2 or high-risk MDS following treatment failures of hypomethylating agents is 4.3 to 5.6 months. We urgently need new therapeutics for these patients with the potential of controlling the disease and offering high quality of life."

Results

The updated median overall survival for all three arms is 259 days or approximately 9 months. The median overall survival for each arm was 291 days or approximately 10 months for Arm G, 290 days or approximately 10 months for Arm H, and 227 days or approximately 8 months for Arm I. Median number of cycles was 3.  Approximately 43% of patients received 4 or more cycles. Median follow-up is 524 days and 13 patients are still alive.  Longer follow-up is needed to assess 1-year survival and overall survival of each arm.

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