MEI Pharma begins ME-344 Phase Ib clinical study in patients with solid tumors

MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that the first patient has been dosed in a Phase Ib clinical study 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.

"ME-344 is an exciting drug candidate with a unique mechanism of action," said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. "In pre-clinical studies, ME-344 showed broad and potent anti-tumor activity, including a model of chemotherapy-resistant ovarian cancer stem cells. Our first-in-human clinical study demonstrated evidence of single-agent activity, including a sustained partial response in a heavily pre-treated patient with small cell lung cancer. We are excited to initiate this second clinical study in order to better assess the potential of ME-344 in combination with chemotherapy."

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.

SOURCE MEI Pharma, Inc.