MEI Announces Results From Phase 1 Study Of Mitochondrial Inhibitor ME-344

(RTTNews) - MEI Pharma, Inc.(MEIP) announced results from a Phase I first-in-human, single-agent clinical study of its investigational mitochondrial inhibitor drug candidate, ME-344, in patients with refractory solid tumors. The results indicated that five of 21 evaluable patients treated with ME-344 experienced progression free survival that was at least twice the duration of their last prior treatment before entry into the study.

ME-344's dose limiting toxicities were observed at both the 15 and 20 mg/kg dose levels, consisting primarily of Grade 3 peripheral neuropathy. Other medically significant adverse events observed in single patients included angina and QTc prolongation at the 10 mg/kg dose. The company said these results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston yesterday.

Based on these results, the company said it is preparing for the Phase Ib trial, that is designed to evaluate the safety and tolerability of ME-344 in combination with Hycamtin in a total of 45 patients with either small cell lung cancer or ovarian cancer. The company expects the Phase Ib trial to begin during the second quarter of 2014. Hycamtin is a chemotherapy approved by the U.S. Food & Drug Administration for the treatment of small cell lung cancer and ovarian cancer, as well as cervical cancer.

"Not only did the trial show evidence of clinical activity, but the primary dose limiting toxicity was consistent with the proposed mechanism of action of ME-344, namely mitochondrial inhibition, suggesting on-target activity." said Robert Mass, MD, Chief Medical Officer of MEI Pharma.