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Astex Pharma Shares On Watch Following Positive Top-Line Data for SGI-0110 in Relapsed/Refractory, Treatment-Naive Acute Myeloid Leukemia


Astex Pharmaceuticals, Inc. (Nasdaq: 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.

Posted-In: News FDA


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