Shares of Cyclacel Pharmaceuticals (NASDAQ: CYCC) are down more than 15% after the company reported that its lead candidate failed to meet its primary endpoint in a phase 3 study of elderly patients with acute myeloid leukemia (AML). The trial did not meet its primary endpoint of demonstrating statistically significant improvement in overall survival (OS) for the experimental arm versus an active control. The secondary endpoint, an improved rate of complete remission (CR), was observed in patients who had discontinued therapy at the time of analysis. Full results from the SEAMLESS study will be submitted for presentation at an upcoming medical conference. “We are disappointed not to have reached the primary endpoint of SEAMLESS. Nevertheless, the improvement in CR rate and similar safety profile are encouraging. We plan to discuss the data with European and US regulatory authorities once subgroup analyses are completed over the next few months and will report our further plans as they develop. We are grateful to the clinical investigators, and especially the patients and their families, for their contributions to this large study,” president and CEO Spiro Rombotis stated in the news release.
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About Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases. Cyclacel’s DNA damage response program is evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in patients with BRCA positive, advanced solid cancers. The transcriptional regulation program is evaluating CYC065, a CDK inhibitor, in patients with advanced cancers. Cyclacel is analyzing stratified and exploratory subgroups from a phase 3 study of sapacitabine in elderly patients with AML. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information, please visit www.cyclacel.com.
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