On May 31, 2017 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that an independent Safety Review Committee completed its pre-specified review of the first cohort of six evaluable patients in a Phase Ib, open-label, dose-escalation study of the Company’s investigational drug candidate ME-401, a potent and selective oral PI3K delta inhibitor, in relapsed refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma (Press release, MEI Pharma, MAY 31, 2017, View Source [SID1234519331]). Schedule your 30 min Free 1stOncology Demo! Based on its review of the safety and efficacy data, the Safety Review Committee declared a minimum biologically effective dose (mBED) for ME-401 at the starting dose of 60 mg and recommended escalation to a 120 mg dose cohort. According to the study protocol, the mBED is defined as a dose that is safe and achieves a response in at least three of six patients. Response assessments are based on criteria of the International Workshop on Chronic Lymphocytic Leukemia for patients with CLL or the Lugano Classification for patients with follicular lymphoma. Response is initially assessed after 8 weeks of therapy.
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To date, all six patients have been on study for a minimum of 10 weeks (range, 10-28 weeks). There have been no reports of ALT AST elevations, colitis or pneumonitis, events commonly reported with other drugs in this class. One patient in the study experienced grade 3 neutropenia that was considered related to study drug. All other adverse events reported were grades 1 or 2. No patients have discontinued due to adverse events. Full data will be submitted for presentation at an upcoming scientific meeting.
"Given the high bar we have placed on the ME-401 program, we are very pleased with the early safety and efficacy data from this study," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "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."
ME-401 is a highly differentiated oral PI3K delta inhibitor that has a distinct chemical structure from other drugs in its class, including the approved drug idelalisib (marketed as Zydelig). Results from a Phase I first-in-human study of ME-401 showed levels of drug exposure that support the potential for an improved therapeutic window compared to idelalisib, with a half-life that supports once-daily dosing.
The ongoing Phase Ib study is designed to determine the minimum biologically effective dose, maximally tolerated dose, dose limiting toxicities and recommended Phase 2 dose of ME-401 while evaluating its safety, efficacy and pharmacokinetics. The study, which opened for enrollment in September 2016, is expected to enroll up to 84 patients at approximately 10 sites. Additional information regarding the study, including inclusion and exclusion criteria, is available at www.clinicaltrials.gov (identifier: NCT02914938).
About ME-401
ME-401 (formerly PWT143) is an orally bioavailable, potent and selective inhibitor of phosphatidylinositol 3 kinase (PI3K) delta, a molecular target that has been shown to play a critical role in the proliferation and survival of certain hematologic cancer cells. Results from a first-in-human, single ascending dose clinical study of ME-401 in healthy volunteers were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2016. The data demonstrated on-target activity at very low plasma concentrations and suggest that ME-401 has a superior pharmacokinetic and pharmacodynamic profile compared to idelalisib. The U.S. Food and Drug Administration approved an Investigational New Drug application for ME-401 in B-cell malignancies in March 2016.
MEI Pharma owns exclusive worldwide rights to ME-401.