Astex Pharmaceuticals, Inc.,a global leader in oncology drug discovery and development, has reported topline results from the ongoing phase II of SGI-110 in patients with AML and MDS. The phase II study is a randomized study of SGI-110 given either as 60 or 90 mg/m2 daily for 5 days in a 28-day course.

As of end of June data cutoff, 67 AML patients had a minimum follow up of three months (50 patients representing the complete cohort of relapsed/refractory AML, and 17 patients in the treatment-naive elderly AML not suitable for induction chemotherapy cohort). The primary endpoint is overall remission rate (Complete Remission or CR; Complete Remission with Incomplete hematologic recovery or CRi/CRp). There were 8 remissions in relapsed/refractory AML and nine remissions in treatment-naive elderly AML for an overall complete remission rate (CR, CRi/CRp) of 17/67 or 25 per cent.

The detailed results have been submitted for presentation to the American Society of Hematology (ASH) meeting during December 7-10 in New Orleans.

SGI-110 is a novel small molecule, DNA-hypomethylating agent administered as a single low volume subcutaneous injection. SGI-110 demonstrated activity in restoring silenced tumor suppressor gene expression in cancer cells by reversal of DNA methylation and inducing responses in previously treated MDS and AML patients. SGI-110 is wholly owned by Astex Pharmaceuticals.

Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology.