Shares of MEI Pharma (NASDAQ: MEIP) are higher in mid-day trade on news that an independent Safety Review Committee has completed its pre-specified review of the first cohort of six evaluable patients in a phase Ib study of the company’s potent and selective oral PI3K delta inhibitor, ME-401, in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma. “PI3K delta inhibitors have demonstrated clear activity in the treatment of CLL and follicular lymphoma, but at the expense of well-defined and substantial toxicities. We believe this provides an opportunity for a highly differentiated drug that is both effective and safe. Now we look forward to demonstrating the therapeutic index of ME-401 across multiple dose cohorts and presenting detailed results later this year,” MEI Pharma president and CEO Daniel P. Gold, Ph.D. stated in the news release. The company said it intends to submit full data from the open-label, dose-escalation study for presentation at an upcoming scientific meeting.
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About MEI Pharma
MEI Pharma, Inc. (NASDAQ: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The company’s portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA. Pracinostat has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for use in combination with azacitidine for the treatment of patients with newly diagnosed AML who are unfit for intensive chemotherapy. Pracinostat is also being developed in combination with azacitidine for the treatment of patients with high and very high-risk myelodysplastic syndrome. MEI Pharma’s clinical development pipeline also includes ME-401, a highly differentiated oral PI3K delta inhibitor currently in a phase Ib study in patients with relapsed/refractory CLL or follicular lymphoma. The company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-sponsored study in combination with bevacizumab for the treatment of HER2-negative breast cancer. Pracinostat, ME-401 and ME-344 are investigational agents and are not approved for use in the U.S. For more information, please visit www.meipharma.com.
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