Date: 2014-10-09
Type of information: DSMB assessment
phase: 3
Announcement: DSMB assessment
Company: Cyclacel Pharmaceuticals (USA - NJ)
Product: sapacitabine
Action
mechanism: nucleoside analog. Sapacitabine is an oral nucleoside analogue prodrug that acts through a novel mechanism. The compound interferes with DNA synthesis by introducing single-strand DNA breaks leading to arrest of the cell division cycle at G2 phase and development of double-strand DNA breaks.
Disease: acute myeloid leukemia
Therapeutic area: Cancer - Oncology
Country:
Trial
details: 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 FDA. The DSMB will perform an interim analysis for futility once half of the required events have been observed.
Latest
news: * On October 9, 2014, Cyclacel Pharmaceuticals, a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, 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 fourth planned safety review and recommended that the study should continue as planned without any modifications. 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.
"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. Over 100 US and European sites are now open and Cyclacel expects completion of enrollment to occur in the next few months.
