In an effort to overcome recruiting challenges for elderly patients with acute myelogenous leukemia, Cyclacel Pharmaceuticals Inc. and FDA agreed on a SPA for a registrational Phase III study that incentivizes enrollment with an active comparator not approved for the indication in the U.S., coupled with an open-label design that encourages patients in the experimental arm to stay in the trial.

Sapacitabine is an analog of the nucleoside cytosine that induces apoptosis of cancer cells in two ways: interfering with DNA synthesis and repair by homologous recombination, and slowing transit through the cell cycle.