On May 5, 2014 MEI Pharma reported that the first patient has been dosed in a Phase Ib clinical study (NCT02100007) of its investigational mitochondrial inhibitor drug candidate ME-344 in combination with Hycamtin (topotecan) in patients with solid tumors, including small cell lung and ovarian cancers. The open-label study is expected to enroll up to 64 patients with preliminary data anticipated by the first quarter of 2015 (Press release MEI Pharma, MAY 5, 2014, View Source [SID:1234500487]).
In October 2013, results from a Phase I clinical study of ME-344 were announced showing preliminary evidence of single-agent activity in patients with refractory solid tumors, including eight of 21 evaluable patients (38%) who achieved stable disease or better. Notably, one patient with small cell lung cancer achieved a confirmed partial response (PR) and still remains on study after more than 89 weeks. ME-344 was generally well tolerated in the study at doses equal to or less than 10 mg/kg delivered on a weekly schedule for extended durations. Dose limiting toxicities were observed at both the 15 and 20 mg/kg dose levels, consisting primarily of Grade 3 peripheral neuropathy.
The Phase Ib study now underway is evaluating the safety and tolerability of intravenous ME-344 in combination with Hycamtin, a chemotherapy approved by the U.S. Food & Drug Administration for the treatment of small cell lung, ovarian and cervical cancers. The initial stage of the study will establish the maximum tolerated dose (MTD) of ME-344 in combination with Hycamtin in up to 24 patients. Once the MTD has been determined, the study will enroll an additional 40 patients into two cohorts: relapsed/refractory small cell lung cancer and platinum-refractory ovarian cancer.
The open-label study is being conducted in collaboration with the Sarah Cannon Research Institute at the University of Oklahoma in Oklahoma City and Tennessee Oncology in Nashville.