Cyclacel's sapacitabine shows anti-leukemic activity

New Jersey-based Cyclacel Pharmaceuticals says that data from a trial of its novel, orally-available nucleoside analog sapacitabine (CYC682) indicate that it has both a favorable safety profile and displays promising anti-leukemic activity. The results, which were announced at this year's meeting of the American Society of Hematology in Atlanta, are derived from a Phase I study of the drug in patients suffering from relapsed or refractory acute myelogenous leukemia or myelodysplastic syndromes.

The firm explained that the primary objective of the ongoing study is to determine the maximum-tolerated dose for twice-daily administration during one of two treatment regimens, either for seven consecutive days of a 21-day cycle, or three consecutive days per week for two weeks every 21 days.

The firm reported that, in the seven-day schedule, a maximum tolerated dose of 375mg was reached, whereas an MTD of 475mg was achieved in the other treatment schedule. Of the 46 patients with AML or MDS in the seven-day schedule, six achieved complete remission either with or without platelet recovery. In addition, 15 trial subjects demonstrated a significant decrease in bone marrow blasts, seven of whom fell to levels of 5% or less.