Astex Pharmaceuticals, Inc. has announced that it has initiated the Phase 2 dose expansion segment of the clinical trial of SGI-110, a novel hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). Treatment-naive MDS and elderly AML (≥65 years) will be enrolled in the dose expansion.
Enrolment in the Phase 2 segment is currently open, and the first patient has been dosed.
The Phase 2 segment includes expansion of the number of patients to approximately 90 patients treated on the five day subcutaneous dosing schedule to better evaluate both efficacy and safety in MDS and AML patients.
“The initiation of SGI-110’s Phase 2 expansion of the clinical trial marks an important milestone for our company as we advance the development of our second-generation hypomethylating agent,” said James S.J. Manuso, PhD, chairman & chief executive officer.
“We are pleased with the advancement of SGI-110 into the Phase 2 segment of the clinical trial. The allowance of treatment-naive MDS and elderly AML patients will be important in evaluating efficacy and safety of SGI-110 in this patient population and to further characterize the clinical differentiation of the drug,” said Mohammad Azab, MD, chief medical officer.
Interim Phase 1 clinical data from subcutaneous SGI-110 was previously reported at the American Association for Cancer Research (AACR) 2012 Annual Meeting in Chicago, IL.
The data showed that SGI-110 has a clear pharmacokinetic differentiation from Dacogen® (decitabine) for Injection given as an IV infusion.
The drug achieved excellent hypomethylation, and major clinical responses in heavily pre-treated AML patients were observed.
Stand Up To Cancer (SU2C) has provided funding for the Epigenetics Dream Team that is collaborating on the scientific evaluation of SGI-110.