Cyclacel Presents Updated Survival Data From The Pilot Study And Lead-In Phase Of Seamless Phase 3 Study At The 2012 ASH Annual Meeting

BERKELEY HEIGHTS, N.J., Dec. 10, 2012 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, announced updated survival data from the pilot study and lead-in phase of SEAMLESS, the Company's randomized, Phase 3, registration-directed study of oral sapacitabine capsules in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for, or have refused, induction chemotherapy. The data were reported at a poster presentation at the 54 ^th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.

"The updated survival data of the sequential administration of sapacitabine and decitabine is promising and provides support for the ongoing SEAMLESS Phase 3 study in elderly patients with newly diagnosed AML," said Hagop Kantarjian, M.D., Chairman & Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and chair of the SEAMLESS study. "Intensive chemotherapy does not benefit most AML patients aged 70 years or older. Median survival by intensive chemotherapy is only 4.6 months and is associated with a 4-week death rate of 26% and an 8-week death rate of 36%. We urgently need better treatment regimens for this patient population."

Pooled Topline Results of the Pilot Phase 1/2 Study and Lead-In Stage of SEAMLESS

Forty-six patients were treated with alternating cycles of sapacitabine and decitabine, which is the treatment regimen in the experimental arm of SEAMLESS. Median age is 77 years (range 70-90). Thirty-three patients (72%) are 75 years or older. Median overall survival is 238 days, or approximately 8 months. The number of patients still alive at 3 months was 38 (83%), at 6 months 30 (65%), at 12 months 16 (35%) and at 18 months 12 (26%). Sixteen patients (35%) survived 1 year or longer. Among 33 patients who are 75 years or older, median overall survival is 263 days, or approximately 9 months, and 1-year survival is 36%. Nineteen patients (41%) responded with 10 complete responses (CRs), 4 partial responses (PRs) and 5 major hematological improvements (HIs). Median time to response is 2 cycles, i.e., one cycle of decitabine and one cycle of sapacitabine (range 1-10). Twenty-seven patients (59%) received 5 or more cycles of treatment. Two dose-limiting toxicities (DLT) were observed (lung infection/sepsis, typhlitis). Thirty-day mortality from all causes was 4%. Sixty-day mortality from all causes was 13% with one death from typhlitis considered to be possibly related to decitabine by investigator assessment. The sequential combination of decitabine and sapacitabine is safe and active.

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