On October 9, 2014 Cyclacel Pharmaceuticals reported that the independent Data and Safety Monitoring Board (DSMB) for the Company’s Phase 3 SEAMLESS study in acute myeloid leukemia (AML) has completed its fourth planned safety review and recommended that the study should continue as planned without any modifications (Press release Cyclacel, OCT 9, 2014, View Source [SID:1234500809]). 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.
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"This is the fourth consecutive review for which the DSMB recommended that the SEAMLESS study should continue as planned," said Judy H. Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. "We are encouraged by the DSMB’s recommendation based on their review of available data from US and European sites participating in SEAMLESS. We now have over 100 US and European sites open and expect completion of enrollment to occur in the next few months. In addition to SEAMLESS, we are conducting feasibility assessment of our Phase 2b randomized study of sapacitabine in older patients with myelodysplastic syndromes (MDS) after treatment failure of hypomethylating agents."
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 (SPA) agreement with the U.S. Food and Drug Administration (FDA). The DSMB will perform an interim analysis for futility once half of the required events have been observed.