Healthcare Industry News: U.S. Food and Drug Administration
News Release - June 15, 2018
MEI Pharma Presents Clinical Data on ME-401 at the European Hematology Association CongressInitiation of registration study for ME-401 in patients with relapsed or refractory follicular lymphoma expected before year-end
SAN DIEGO, June 15, 2018 -- (Healthcare Sales & Marketing Network) -- MEI Pharma, Inc. (NASDAQ: MEIP) a pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer, today announced that results from a Phase 1b study of ME-401 in patients with relapsed or refractory follicular lymphoma (FL), chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL) are being presented during a poster presentation today, Friday, June 15, 2018 at the 23rd Congress of the European Hematology Association (EHA) in Stockholm, Sweden. Complete data results on the Phase 1b study were previously announced at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in June 2018.
"The data demonstrates that ME-401 achieved a 90% response rate across all patient groups treated and was generally well tolerated with no dose-limiting toxicities identified at any dose level," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "The full data from our ME-401 study is very encouraging and we expect to initiate a registration study for ME-401 this year for the treatment of adults with relapsed or refractory FL."
ME-401 is being evaluated in a Phase 1b dose escalation study in patients with relapsed or refractory FL, CLL and SLL. As of May 14, 2018, 46 patients were enrolled: 31 patients received monotherapy and 30 were evaluable for efficacy (12 patients at 60 mg, 12 patients at 120 mg and six patients at 180 mg). Based on the data, the Company determined that no further dose escalation was required. An expansion cohort of up to 30 patients with FL, CLL and SLL was added to further evaluate the safety and efficacy of ME-401 as a single agent at the 60 mg dose. An additional 15 patients are enrolled in the study arm evaluating ME-401 (60 mg) in combination with rituximab (marketed as RituxanŽ) in patients with various B cell malignancies.
The ME-401 EHA 2018 poster can be accessed on the MEI Pharma website.
ME-401 is a next-generation selective oral inhibitor of phosphatidylinositol 3-kinase ("PI3K") delta. PI3K delta is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancer cells. ME-401 displays high selectivity for the PI3K delta isoform and is in a chemical class that is distinct from other PI3K delta inhibitors with a differentiated pharmaceutical profile including: long on target residence time, preferential cellular accumulation, large volume of distribution, and a 28-hour half-life suitable for once-daily oral administration. The pharmaceutical properties and clinical data generated to date for ME-401 support its potential as a single-agent therapy and the potential to be used in combination with existing or emerging therapies to treat multiple difficult-to-treat oncology indications.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new 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 acute myeloid leukemia (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 (MDS) (NCT03151304). MEI Pharma's clinical development pipeline also includes ME-401, a highly differentiated oral PI3K delta inhibitor currently in a Phase 1b study in patients with relapsed/refractory follicular lymphoma or CLL, and voruciclib, an oral, selective CDK inhibitor shown to suppress MCL1, a known mechanism of resistance to BCL2 inhibitors. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-initiated study in combination with bevacizumab evaluating patients with HER2-negative breast cancer. Pracinostat, ME-401, ME-344 and voruciclib are investigational agents and are not approved for use in the U.S. For more information, please visit www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
Source: MEI Pharma
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.