30 October 2020 - - Japanese pharmaceutical company Otsuka Pharmaceutical Co., Ltd's US-based Astex Pharmaceuticals, Inc subsidiary has entered into a Cooperative Research and Development Agreement with the US National Cancer Institute, part of National Institutes of Health, the company said.

The agreement calls for a range of new clinical and translational studies of oral decitabine and cedazuridine tablets as an anticancer agent to be conducted in collaboration with Astex.

The NCI's Cancer Therapy Evaluation Program has announced they are accepting Letters of Intent for evaluation of oral decitabine and cedazuridine tablets in hematological malignancies and solid tumors, including in combination with other investigational agents.

Study proposals will be reviewed by CTEP and by Astex.

On July 7th, 2020, Astex's hypomethylating agent INQOVI (decitabine and cedazuridine) 35mg/100mg tablets, for oral use, was approved simultaneously by the US FDA and by Health Canada for the treatment of intermediate- and high-risk myelodysplastic syndromes and chronic myelomonocytic leukemia patients in the US and Canada, respectively.

The initial study being conducted under the CRADA will investigate the combination of oral decitabine and cedazuridine tablets with venetoclax in the treatment of acute myeloid leukemia.

The CRADA will also include oral decitabine and cedazuridine tablets in the NCI myeloMATCH master trial aimed at evaluating therapies for the treatment of myeloid malignancies. Astex will provide funding, study drug, and personnel to support the proposed studies.

In the US and Canada, INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes, including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.