Astex Pharmaceuticals to Submit IND Application to FDA for ASTX727

Astex Pharmaceuticals

announced today its plan to submit an Investigational New Drug or IND application to the Food and Drug Administration (FDA) for ASTX727, a novel oral hypomethylating agent (HMA) in the fourth quarter of this year. ASTX727 is intended as a fixed dose oral combination product consisting of decitabine and E7727, a novel cytidine deaminase inhibitor (CDAi) licensed from Eisai Inc. ASTX727 allows for an efficient oral delivery of decitabine at low doses. Relevant animal studies revealed that the product can result in therapeutic exposures of decitabine at low doses. The profile of E7727 is expected to result in low inter-patient variability across doses of decitabine with little or no gastrointestinal safety issues.  Later this year, preclinical data on ASTX727 will be submitted for presentation at a scientific meeting.