Specific patient populations include elderly patients who have previously untreated disease or adult patients who have relapsed or refractory disease.
Key objectives of the study will be to determine the efficacy of MGCD0103 as a treatment option for these patients. Secondary objectives include determining the safety profile, as well as assessing biomarkers and predictive markers for MGCD0103. The trial is expected to last up to 24 months.
“We previously reported encouraging results from our phase I trial – four of nine patients, at the highest dose tested, had reductions in bone marrow blasts, including three complete bone marrow responses,” said Mr Donald Corcoran, president and CEO of MethylGene.
“With that promising data, we are now progressing MGCD0103 into additional phase II trials with a goal to demonstrate the activity and safety of MGCD0103 in patients afflicted with these cancers.”