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MEI Pharma's Mitochondrial Inhibitor ME-344 Shows Preliminary Evidence Of Single-Agent Activity In First-in-Human Clinical Study

SAN DIEGO, Oct. 21, 2013 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, 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, presented yesterday at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, indicated that five of 21 evaluable patients treated with ME-344 experienced progression free survival (34 to 61+ weeks) that was at least twice the duration of their last prior treatment before entry into the study.

(Logo:  http://photos.prnewswire.com/prnh/20120628/LA32362LOGO)

In addition, the presentation highlighted that one of these 5 patients, a heavily pre-treated patient with small cell lung cancer, achieved a confirmed partial response. The patient received his first treatment of ME-344 in August 2012 and has now been on study for more than 61 weeks. His June 2013 scans showed a decrease of 32% in target lesions, which was confirmed in his most recent scans ( August 2013). This patient and three others remain on study and continue weekly dosing.

"The observed radiographic partial response is promising, particularly in such a difficult-to-treat disease as small cell lung cancer," said presenter and co-investigator Jeffrey R. Infante, MD, Director, Drug Development at Sarah Cannon Research Institute and Tennessee Oncology. "In addition to tumor shrinkage, this patient has also demonstrated symptomatic improvement while on study, including decreased cough, shortness of breath and improved performance status. The results 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.

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