Cyclacel Pharma Announces Data Safety Monitoring Board Recommends Continuation of SEAMLESS Study of Sapacitabine in AML
Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC) (Nasdaq: CYCCP) (Cyclacel or the Company), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders today announced 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 third planned safety review and recommended that the study should continue as planned without any modifications. 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.
"We are encouraged by the DSMB's recommendation after the latest safety review of available data from US sites participating in the SEAMLESS study. We are presently expanding the study into Europe and expect to at least double the number of sites before completing enrollment," said Judy H. Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. "We look forward to reporting further updates from SEAMLESS and, separately, primary endpoint data of our Phase 2 study of sapacitabine in older patients with myelodysplastic syndromes (MDS) after treatment failure of hypomethylating agents at the ASH conference in early December."
SEAMLESS is a Phase 3, randomized, registration-directed study of oral sapacitabine capsules in elderly patients with AML who are unfit or have refused intensive chemotherapy. The primary endpoint is overall survival. SEAMLESS is being conducted under a Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA).
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