Guadecitabine (SGI-110) is a novel hypomethylating dinucleotide of decitabine (DAC) and deoxyguanosine that is resistant to degradation by cytidine deaminase and results in prolonged in vivo exposure to its active moiety DAC. The differentiated pharmacokinetic profile offers the potential of improved biological and clinical activity and safety over currently available HMAs. We reported previously results from the Phase 1 dose-escalation study in AML and MDS1 and the Phase 2 randomized dose-response study in r/r AML patients of SGI-110 given SC at 2 doses (60 and 90 mg/m2) in a 5-day regimen2 or at 60 mg/m2 in a 10-day regimen3. Here we report an overall assessment of the association between clinical responses, global DNA demethylation assessed by LINE1 assay and baseline expression of a panel of 7 genes (CDA, P15, P21, DNMT3B, DNMT3A, DNMT1 and CTCF) assessed by qRT-PCR.
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2015_ESH-AML: Baseline biomarkers and DNA demethylation correlate w. clinical responses in SGI-110