December 16, 2009 (FinancialWire) — Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) (NASDAQ: CYCCP) said it recently held a Type A meeting with the U.S. Food and Drug Administration to discuss a randomized Phase 3 study design for Cyclacel’s oral sapacitabine capsules in acute myeloid leukemia and separately in myelodysplastic syndromes .

Based on the FDA’s confirmation that the proposed study design would be acceptable for a Special Protocol Assessment, Cyclacel plans to submit a SPA request during the first quarter of 2010.

At the 51st annual meeting of the American Society of Hematology, the company reported data from a randomized Phase 2 study including promising 1-year survival in a difficult to treat population of elderly patients with AML aged 70 years and activity in older patients with MDS refractory to hypomethylating agents.

The study uses a selection design with the objective of identifying a dosing schedule which produces a better 1-year survival rate in the event that all three dosing schedules are active. The study enrolled 60 patients aged 70 or older with either untreated AML or AML in first relapse randomized across three dosing schedules of sapacitabine (Arm A, a 7-day low dose regimen; Arm B, a 7-day high dose regimen and Arm C, a 3-day high dose regimen). Each arm enrolled and treated 20 patients. Approximately 55% of patients had AML de novo and the rest had AML preceded by antecedent hematological disorder, such as MDS or myeloproliferative disease.

The primary endpoint of 1-year survival was 35% on Arm A, 30% on Arm C and 10% on Arm B. The median overall survival was 212 days on Arm C (range of 13 to over 654 days), 197 days on Arm A (range of 26 to over 610 days) and 100 days on Arm B (range of 6 to over 646 days). Overall response rate, a secondary endpoint, was 45% on Arm A, 35% on Arm C and 25% on Arm B with CR rate of 25% on Arm C and 10% on Arms A and B. Thirty-day mortality was 10.0% on Arm C and Arm A and 20.0% on Arm B. Approximately 30% of all patients received sapacitabine for at least 6 cycles. Fifteen patients who survived one year or more received an average of 12 treatment cycles and 7 patients are still on study receiving sapacitabine.

Exploratory subgroup analysis suggests that (i) Arm C may be more effective for de novo AML and Arm A may be more effective for AML preceded by AHD, such as MDS.

The 3-day dosing schedule in Arm C was selected for further clinical development in elderly patients with de novo AML based on a 1-year survival rate of 30%, ORR of 35% with durable CRs. The 7-day dosing schedule in Arm A was selected for further clinical development in elderly patients with AML preceded by AHD based on a 1-year survival rate of 35%, ORR of 45% with durable hematological improvement.

Cyclacel also reported interim response data for the ongoing Phase 2 clinical trial of sapacitabine in older patients with MDS.

The study has recently completed enrollment of 60 patients aged 60 or older with MDS who were previously treated with azacitidine and/or decitabine. Each arm enrolled 20 patients randomized across the same three dosing schedules of sapacitabine (Arms A, B and C) tested in the AML stratum of the study. Forty-nine of the patients enrolled have been followed-up for more than 30 days. Approximately 46% of the 49 patients had baseline bone marrow blast counts above 10%.

Based on interim data, the highest number of responses was observed on Arm B, the 7-day high dose schedule. Thirty-day mortality from all-causes is 8.2%. Approximately 30% of the patients received 4 or more cycles of sapacitabine.

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