Astex Pharma To Submit IND Application To FDA For ASTX727 - Quick Facts

(RTTNews) - Astex Pharmaceuticals, Inc. (ASTX) said its plan to submit an Investigational New Drug or IND application to the Food and Drug Administration for ASTX727, a novel oral hypomethylating agent or HMA in the fourth quarter of this year.

ASTX727 is intended as a fixed dose oral combination product, comprising decitabine and E7727, a novel cytidine deaminase inhibitor licensed from Eisai Inc. ASTX727 allows for an efficient oral delivery of decitabine at low doses. Relevant animal trials showed that the product can lead to therapeutic exposures of decitabine at low doses.

The profile of E7727 is likely to result in low inter-patient variability across doses of decitabine with little or no gastrointestinal safety issues. The preclinical data on ASTX727 would be submitted for presentation at a scientific meeting later this year.