eClinical Technology and Industy News

MEI Pharma Reports Initial Data from Clinical Study Evaluating ME-344 in Combination with Bevacizumab (Avastin®) in Relapsed Metastatic Colorectal Cancer Patients

– Cohort 1 Exceeds Predetermined Non-Progression Threshold in the Ongoing Phase 1b Study –

– ME-344 in Combination with Bevacizumab was Generally Well-tolerated with no Evidence of Overlapping Toxicity –

– MEI to Continue Advancing ME-344 via Development of a New Formulation with the Potential to Increase Biological Activity, Patient Convenience and Commercial Opportunity –

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, today reported that 25% of evaluable patients with relapsed metastatic colorectal cancer (“mCRC”) in Cohort 1 of the ongoing Phase 1b study evaluating ME-344, an investigational inhibitor of mitochondrial oxidative phosphorylation (“OXPHOS”), in combination with bevacizumab (Avastin®) had no disease progression at Week 16. This landmark analysis exceeded the 20% threshold set in the Clinical Study Protocol to add an additional 20 patients to the study via the initiation of Cohort 2. The combination was also observed to be generally well-tolerated to date. While the threshold was met to proceed to Cohort 2, it was separately reported today that following a strategic review, the Company decided to continue to advance ME-344 development via its ongoing development of a new formulation rather than through the addition of a new cohort. The Company believes this represents the optimal approach to leveraging the potential of the program. The Company has already initiated research and development activity of the new formulation with encouraging results, with the goal of increasing biological activity, improving convenience of administration and increasing commercial opportunity.

“The data reported today, including progression-free survival, overall survival, and safety results of the combination, represent an important development supporting the potential of ME-344 in combination with Avastin to induce synthetic lethality in tumors using a completely novel therapeutic strategy,” said Richard Ghalie, chief medical officer of MEI Pharma. “The development of a new formulation with enhanced biologic activity is aimed at further improving patient outcomes and treatment convenience in a well-tolerated manner.”

“At MEI we are committed to our mission of developing novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, and ME-344 holds significant potential as a novel therapeutic strategy to advance this mission,” said David Urso, president and chief executive officer of MEI Pharma.

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