Astex up on data for second-generation Dacogen

Astex Pharmaceuticals Inc. (NASDAQ:ASTX) added $1.34 (24%) to $6.82 on Wednesday after reporting that subcutaneous once-daily SGI-110 led to an overall remission rate of 25% in 67 evaluable acute myelogenous leukemia (AML) patients in the Phase II portion of the Phase I/II SGI-110-01 trial to treat myelodysplastic syndrome (MDS) and AML. Remission was defined as complete remission or complete remission with incomplete hematologic recovery. SGI-110 led to nine remissions in 17 treatment-naïve elderly AML patients who were not suitable for induction chemotherapy and eight remissions in 50 relapsed/refractory AML patients. Astex said that no formal threshold has been established for meeting the endpoint, the primary for the Phase II portion of the trial.

By year end, Astex plans to complete enrollment of over 250 patients in the Phase II portion of the trial, which is slated to enroll patients with relapsed/refractory or treatment-naïve MDS or AML. A Phase III trial is slated to start next year, but the specific indication for the Phase III trial has not yet been determined. SGI-110 (formerly S110), a small molecule DNA (cytosine-5-)-methyltransferase 1 (DNMT1) inhibitor, is a second-generation version of Astex's MDS drug Dacogen decitabine. ...