Cyclacel Pharmaceuticals Inc. reported on the progress of its clinical programs at an end of year earnings call on March 27th. In particular, management detailed progress in accruing patients to its pivotal SEAMLESS trial of sapacitabine, an oral nucleoside analogue prodrug, in elderly patients with newly diagnosed acute myeloid leukemia (AML). However, an analyst question about a European Phase II “pick the winner” trial, in which the Data Monitoring and Ethics Committee recommended that the sapacitabine arm be stopped for futility, raised questions about the potency of the agent on its own.
The Phase III SEAMLESS trial is a randomized, two-arm study comparing a regimen of oral sapacitabine dosed in alternating cycles...