Astex Pharmaceuticals, Inc. (NASDAQ: ASTX) is the NASDAQ pre-market leader this morning on news that its subcutaneous SGI-110 interim phase I.II MDS and AML data demonstrated differentiated PK profile and good tolerability, as well as a preliminary promising complete responses in heavily pre-treated acute myelogenous leukemia patients enrolled in the Phase 1 segment of the trial.
The randomized Phase 1/2 first-in-human dose escalation study had 66 patients enrolled who were previously treated as of March 28, 2012.
In the data, two of the seven evaluable refractory AML patients with adequate hypomethylation with no prior resistance to hypomethylating agents showed a complete response and one patient showed partial response.
The pharmacokinetic data suggests delivery of decitabine by SGI-110 achieves high decitabine exposure. It also showed a longer half life and a potent dose-dependent hypomethylation induction in the daily regimen.
Shares are trading higher by 13.6% at $2.09 in the pre-market and the 52-week trading range is $1.51 to $3.35. The market cap before the news was a mere $171 million.
JON C. OGG