6:01AM Astex Pharma announces subcutaneous SGI-110 interim phase 1/2 MDS and AML data presentation at AACR (ASTX) 1.84 : Co announced that interim Phase 1/2 clinical data from subcutaneous SGI-110 demonstrated differentiated PK profile, good tolerability, and preliminary promising complete responses in heavily pretreated acute myelogenous leukemia (AML) patients enrolled in the Phase 1 segment of the trial. The randomized Phase 1/2 first-in-human dose escalation study enrolled 66 patients with previously treated intermediate or high-risk myelodysplastic syndromes or AML as of March 28, 2012. Of seven evaluable refractory AML patients who had adequate hypomethylation with no prior resistance to hypomethylating agents,two showed complete response, and one showed partial response. Additionally, the pharmacokinetic data suggests delivery of decitabine by SGI-110 achieves high decitabine exposure and longer half life than decitabine intravenous infusion. The pharmacodynamic data shows potent dose-dependent hypomethylation induction in the daily regimen. The primary objective in the dose escalation segment was to estimate the optimal biologically effective dose and/or the maximum tolerated dose. The primary objective in the dose expansion segment will be estimating overall remission rates. Secondary objectives include estimating the incidence and severity of dose limiting toxicity, the PK profile of SGI-110 and decitabine, rates of hematologic improvement and duration of remission, time to disease progression, overall survival rate, and incidence of blood and platelet transfusions. The PD studies suggest the optimal BED was reached prior to the MTD.
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