Cyclacel's sapacitabine fails in Phase III AML trial

Cyclacel Pharmaceuticals Inc. (NASDAQ:CYCC) lost $1.36 (25%) to $4.05 on Thursday after its sapacitabine (CYC682) missed the primary endpoint in the pivotal Phase III SEAMLESS trial to treat newly diagnosed acute myelogenous leukemia in elderly patients. COO Paul McBarron told BioCentury that it will meet with FDA to determine whether data from SEAMLESS could support an NDA submission after the company completes subgroup analyses “over the next few months."

On the primary endpoint, alternating cycles of oral sapacitabine and Dacogen decitabine did not significantly improve overall survival (OS) vs. Dacogen alone...