Cyclacel Announces Data Safety Monitoring Board Recommendation to Continue the SEAMLESS Phase 3 Trial of Sapacitabine
Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC), today announced that the independent Data Safety Monitoring Board of SEAMLESS, the Phase 3, randomized, registration-directed study of sapacitabine in elderly patients with acute myeloid leukemia, recommended that the study should enter the randomized stage as planned.
The DSMB reviewed available data from a total of 46 patients receiving oral sapacitabine capsules, the Company's lead product candidate, administered in alternating cycles with decitabine. The DSMB noted that no safety or efficacy concerns were identified. The DSMB review was mandated in the Special Protocol Assessment agreement that Cyclacel entered into with the U.S. Food and Drug Administration with regard to the SEAMLESS study protocol.
