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DUBLIN, Calif., Sept. 30, 2013 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced that detailed clinical responses and biomarkers data of relapsed/refractory AML (r/r AML) patients treated in the Phase 1 part of the SGI-110-01 study were presented at the European Cancer Congress (ECC: ECCO-ESMO-ESTRO) in Amsterdam, Netherlands.
The data were presented in the Oral Papers Session of Hematological Malignancies on Saturday, September 28, by Professor Jean-Pierre Issa, MD, Director, Fels Institute for Cancer and Molecular Biology, Temple University, Philadelphia, PA. The presentation title was: "Study of the correlation of baseline biomarkers and DNA demethylation to clinical responses in a Phase 1/2 randomized study of SGI-110, a novel subcutaneous hypomethylating agent, in the treatment of relapsed/refractory acute myeloid leukemia."
The presentation showed that of the 50 heavily pre-treated Phase 1 AML patients with LINE-1 DNA methylation data, there were 5 Complete Responses, or 10% (2 CRs, 1 CRp, and 2 CRi). There were no responders in the 31 patients (0%) who had LINE-1 DNA demethylation of less than 10% after treatment, while all 5 responders were in the 19 patients (26%) who had LINE-1 demethylation of at least 10% (0 vs. 26%, p <0.01). The median duration of response was approximately 4 months (114 days), and two responders had complete responses for approximately 1 and 1.5 years (350, and 558 days respectively). Two of the 5 responders had prior hypomethylating agent treatment, and two patients had prior bone marrow transplants. Patients with low baseline DNMT-3b expression seemed to correlate with better LINE-1 demethylation and response. Other baseline biomarkers -- Cytidine deaminase (CDA), deoxycytidine kinase (dCK) and micro-RNA 29b -- did not seem to correlate with either LINE-1 demethylation or clinical response.
The first data from the Phase 2 AML patients in both r/r AML and treatment-naïve elderly AML were submitted for presentation at the upcoming 2013 American Society of Hematology Annual Meeting, December 7-10, New Orleans, LA. Top line data on the complete cohort of r/r AML patients, and 17 treatment-naïve elderly AML patients were released on August 28, 2013.