Cyclacel Reports Disappointing Outcome From Interim Analysis Of SEAMLESS Study

(RTTNews) - Cyclacel Pharmaceuticals Inc. (CYCC, CYCCP) reported recommendations of the independent Data and Safety Monitoring Board (DSMB) of the company's Phase 3 SEAMLESS study of oral sapacitabine capsules in acute myeloid leukemia, or AML. The DSMB conducted its planned interim analysis for futility after 247 events and the final safety review of 470 randomized patients. The planned futility boundary has been crossed and the DSMB determined that based on available interim data, it would be unlikely for the study to reach statistically significant improvement in survival. The DSMB found no safety concerns.

The company said it will follow-up patients as per the study protocol until the prespecified 424 events have been observed. This is estimated to occur between the second half of 2015 and the first half of 2016. The SEAMLESS study 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 from approximately 110 U.S. and European sites. The primary endpoint is overall survival.