Investment Research and Business Due Diligence
Thursday, August 29, 2013
Positive topline data on SGI-110 in AML drives Astex Pharma stock up 25%
Astex Pharmaceuticals, Inc. (Nasdaq:ASTX) announced topline results from the ongoing phase 2 study on SGI-110 in patients with AML and MDS. In the trial, SGI-110 was 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 3 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 9 remissions in treatment-naive elderly AML for an overall complete remission rate (CR, CRi/CRp) of 17/67 or 25%. The detailed results have been submitted for presentation to the American Society of Hematology (ASH) meeting to be held later this year during December 7-10 in New Orleans, LA.
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.
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