Entries by Peggy Bickerton

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.

9 December 2019 in , /by

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 […]

Taiho Oncology Announces Agreement with Otsuka to Commercialize Astex Pharmaceuticals’ Drug Candidates

7 June 2019 in , /by

PRINCETON, N.J., June 7, 2019 – Taiho Oncology, Inc. announces that it has assumed commercialization responsibility from Otsuka Pharmaceuticals Co., Ltd., (Otsuka) for the novel fixed-dose combination of cedazuridine and decitabine (ASTX727) and guadecitabine (SGI-110) in the U.S. and Canada, subject to regulatory approvals. Taiho Pharma Canada, Inc., will commercialize these compounds in Canada. The […]

Astex Pharmaceuticals and Otsuka announce results of the phase 3 ASCERTAIN study of the novel oral cedazuridine and decitabine fixed-dose combination (ASTX727) in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML)

6 June 2019 in , /by

Cedazuridine and decitabine, administered orally as a fixed-dose combination (ASTX727), met the primary endpoint of decitabine exposure equivalence of total 5-day dosing between oral ASTX727 and IV decitabine in the phase 3 ASCERTAIN study in MDS and CMML patients The study confirmed that the safety profile and clinical activity of the cedazuridine and decitabine fixed-dose […]