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MEI Pharma's Mitochondrial Inhibitor ME-344 Shows Preliminary Evidence of Single-Agent Activity in First-in-Human Clinical Study
Date:10/21/2013

of this single agent Phase I study are encouraging and further clinical development of ME-344 is warranted."

A copy of yesterday's poster presentation, entitled "ME-344, a novel mitochondrial oxygenase inhibitor: Results from a first-in-human Phase I study," is now available at www.meipharma.com.

ME-344 was generally well tolerated 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. Other medically significant adverse events observed in single patients included angina and QTc prolongation at the 10 mg/kg dose.

"We are encouraged by the results from this first-in-human study of ME-344," said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. "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. Based on these findings, we are now actively preparing for a Phase Ib clinical trial of ME-344 in combination with Hycamtin® (topotecan) in small cell lung cancer and ovarian cancer, which we expect to initiate during the second quarter of 2014."

The Phase Ib trial will be 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. 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.

About ME-344
ME-344 is MEI Pharma's isoflavone-derived mitochondrial inhibitor drug candidate. In preclinical studies, ME-344 has been shown to cause caspase-independent
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SOURCE MEI Pharma, Inc.
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