Cyclacel opens Ph II sapacitabine trial in AML

The USA's Cyclacel Pharmaceuticals has initiated an open-label, multicenter, randomized Phase II clinical trial of its oral drug candidate, sapacitabine, in elderly patients with acute myeloid leukemia who are previously untreated or in first relapse.

According to the firm, this study follows the encouraging anti-leukemic activity observed in a Phase I trial in patients with advanced leukemias or myelodysplastic syndromes in which previously-treated subjects with AML or MDS achieved complete remission or complete remission without platelet count recovery. The agent is also undergoing Phase II evaluation in patients with advanced cutaneous T-cell lymphoma and has been given as a single agent to approximately 170 patients in four Phase I studies.

The primary objective of this latest Phase II study is to evaluate the one-year survival rate of three dosing schedules of sapacitabine in elderly patients with previously-untreated or first relapsed AML. Secondary objectives are to assess the number of people who have achieved a CR or CR without blood count recovery, duration of CR or CRi, transfusion requirements, number of hospitalized days and safety.