Cyclacel Pharma Says DSMB Recommends To Continue SEAMLESS Phase 3 Study In AML

(RTTNews) - Cyclacel Pharmaceuticals Inc. (CYCC, CYCCP) announced that the independent Data and Safety Monitoring Board or DSMB for the Company's Phase 3 SEAMLESS study in acute myeloid leukemia or AML has completed its fourth planned safety review and recommended that the study should continue as planned without any modifications.

The DSMB reviewed available data from 317 randomized patients with at least 60 days of follow-up and noted that no safety or efficacy concerns were identified.

SEAMLESS is a Phase 3, randomized, registration-directed study of oral sapacitabine capsules in elderly (70 years or older) patients with AML who are unfit for or have refused intensive chemotherapy. The primary endpoint is overall survival. SEAMLESS is being conducted under a Special Protocol Assessment or SPA agreement with the U.S. Food and Drug Administration or FDA. The DSMB will perform an interim analysis for futility once half of the required events have been observed.