Cyclacel fully enrolled for Ph II AML trial

The USA's Cyclacel Pharmaceuticals has completed enrollment of its Phase II trial of sapacitabine, the company's oral nucleoside analog, in elderly patients with acute myeloid leukemia.

The study is an open-label, multicenter, randomized Phase II trial of oral sapacitabine with two separate strata: elderly patients with AML who are previously untreated or in first relapse and myelodysplastic syndromes patients who have been previously treated with hypomethylating agents. In total, the trial will enroll approximately 120 patients with around 60 in each stratum.

The primary objective of the study is to evaluate the one-year survival rate of three dosing schedules. The study uses a selection design with the objective of identifying a dosing schedule which produces a better one-year survival rate for each stratum in the event that all three dosing schedules are active. Interim findings from this trial are expected to be available by the end of 2008 and final results during the second half of 2009.