Cyclacel
Pharmaceuticals, Inc. CYCC 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).
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Posted In: News
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in