SGI-110: Interim Phase I/II data
Interim data from 66 patients with MDS or AML in the dose-escalation Phase I portion of an open-label, U.S. Phase I/II trial showed 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). Additionally, SGI-110 produced a higher exposure and had a longer half-life than the company's IV Dacogen decitabine (about 1.5-2.5 vs. about 0.6 hours). Furthermore, the pharmacodynamic profile of SGI-110 showed that the daily regimen led to dose-dependent hypomethylation induction. Treatment-related serious adverse events included febrile neutropenia, pseudomonal sepsis, chest pain, atrial fibrillation (AF) and pleural effusion. Patients received 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 company expects interim data in 4Q12 from the dose-expansion Phase II portion, which plans to enroll 50-100 patients 65 years or older with MDS or AML. Data were presented at the American Association for Cancer Research meeting in Chicago. ...