SGI-110: Interim Phase I/II data

Interim data from 15 evaluable intermediate- and high-risk MDS patients who received prior azacitidine or decitabine therapy in the dose-escalation Phase I portion of the open-label, U.S. Phase I/II SGI-110-01 trial showed that subcutaneous SGI-110 led to an overall response rate (ORR) of 40%. Median duration of response was 92 days. The most common adverse event reported was injection site pain and myelosuppression. Data were presented at the European Hematology Association meeting in Stockholm. Additional data from relapsed or refractory AML patients from the Phase I portion will be presented at the European Society for Medical Oncology meeting in Amsterdam in September.

Last year, Astex reported data from 66 patients with MDS or AML in the Phase I portion showing that subcutaneous SGI-110 led to 2 complete responses and 1 partial response in patients with refractory AML and no prior resistance to hypomethylating agents (n=7) (see BioCentury, April 23, 2012). The Phase I portion enrolled 78 patients with relapsed or refractory, intermediate- and high-risk MDS or AML to receive once-daily 3-90 mg/m ² SGI-110 for 5 days or once-weekly 6-125 mg/m ² SGI-110 for 3 weeks in a 28-day cycle. The Phase II portion will enroll up to 200 patients, including treatment-naïve patients, to receive 60 and 90 mg/m ² SGI-110 once daily for 5 days. ...