SGI-110 Phase 2 Shows Clear Activity in Patients With Acute Myeloid Leukemia
DUBLIN, Calif., Aug 28, 2013 (GLOBE NEWSWIRE via COMTEX) -- Astex Pharmaceuticals, Inc. ASTX today announced topline results from the ongoing phase 2 of SGI-110 in patients with AML and MDS. The Phase 2 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 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.
About Astex Pharmaceuticals
Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. The Company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies. Astex Pharmaceuticals developed and out-licensed DACOGEN(R) (decitabine) for Injection and receives significant royalties on global sales.
For more information about Astex Pharmaceuticals, Inc., please visit http://www.astx.com.