The study achieved its primary objective of decitabine systemic exposure equivalence between oral ASTX727 and IV decitabine with an oral/IV ratio of approximately 99% Safety findings were consistent with those anticipated for IV administered decitabine; the most common Adverse Events were hematological. Astex plans to file a New Drug Application (NDA) with the US FDA … Continue reading Astex Pharmaceuticals presents topline data from the ASCERTAIN phase 3 study of its novel, oral hypomethylating agent cedazuridine and decitabine (ASTX727) in MDS and CMML at the American Society of Hematology Meeting in Orlando, FL.