Cyclacel: Independent Monitoring Board Supports Sapacitabine Phase 3 Study

(RTTNews) - Cyclacel Pharmaceuticals Inc. (CYCC, CYCCP), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, announced that the independent Data and Safety Monitoring Board, or DSMB, for the company's Phase 3 SEAMLESS study in acute myeloid leukemia has completed its third planned safety review and recommended that the study should continue as planned without any modifications.

SEAMLESS is a Phase 3, randomized, registration-directed study of oral sapacitabine capsules in elderly patients with acute myeloid leukemia who are unfit or have refused intensive chemotherapy. The primary endpoint is overall survival.

The DSMB reviewed available data from 212 randomized patients and noted that no safety or efficacy concerns were identified. The DSMB will conduct additional periodic reviews of each 100 patients and will also perform a futility assessment once half the required events have been observed, the company said.