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Updated Phase 2 Survival Data Of Cyclacel's Sapacitabine For MDS Presented At The Eighth Annual Hematologic Malignancies 2012 Conference

Stocks in this article: CYCC

BERKELEY HEIGHTS, N.J., Oct. 12, 2012 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company) announced that updated 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®), will be discussed at two separate sessions at The Eighth Annual Hematologic Malignancies 2012 Conference being held on October 10-14, 2012, in Houston, Texas. Median overall survival to date for all 63 patients is 252 days or approximately 8 months. Median overall survival for 41 out of 63 patients with 10% or more blasts in their bone marrow is 274 days or approximately 9 months.

"The updated survival data reported from this sapacitabine study in MDS patients after treatment failures of hypomethylating agents are impressive in 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. "If they are reproduced in subsequent studies, sapacitabine may become a new treatment standard for older patients."

"MDS patients have a poor outcome after treatment failures with front-line therapies. The updated survival data support previously reported data indicating 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. "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 effective therapies for these patients."

Results

The updated median survival for all three arms is 252 days (approximately 8 months). The median survival for each arm was 291 days (approximately 10 months) for Arm G, 274 days (approximately 9 months) for Arm H, and 227 days (approximately 8 months) for Arm I. Twenty-seven percent of all patients received 6 or more cycles. Twenty-two percent of patients are still alive and longer follow-up is needed to assess 1-year survival and overall survival of each arm.

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