Cyclacel cancer candidate shows promising results

The New Jersey-based biopharmaceutical company said that the drug had a favorable safety profile and promising anti-leukemic activity in patients with relapsed and refractory acute myelogenous leukemia and myelodysplastic syndromes.

The study is ongoing at The University of Texas MD Anderson Cancer Center. In the trial, 35 patients were treated twice daily for seven consecutive days every 21 days at doses between 75 and 375mg per day. The recommended phase II dose was determined to be 325mg twice daily. The best responses were complete remissions or complete remissions without platelet recovery in four patients.

In addition, 11 patients had more than a 50% decrease in bone marrow blasts including 7 with blast reduction to 5% or less. Although one patient treated at 375mg died of complications from neutropenic colitis, Cyclacel said that non-hematological toxicities were mostly mild to moderate. An additional five patients were treated by a three-day schedule at doses of 375mg and 425mg. This part of the study is ongoing.

Spiro Rombotis, president and CEO of Cyclacel, said: “These results, along with data from our solid tumor studies, suggest that sapacitabine oral capsules may be active in both hematological and solid tumors. If further data are confirmatory this would be an exciting development in terms of sapacitabine's commercial potential as anticancer drugs are rarely active in both oncology and hematology.”