May 16, 2018
SAN DIEGO, May 16, 2018 /PRNewswire/ -- 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 the publication of two data abstracts related to MEI Pharma's clinical stage drug development programs to be presented at the 2018 ASCO Annual Meeting to be held June 1-5, 2018 in Chicago. Study investigators will present updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory indolent B-cell malignancies and from an investigator-initiated study of ME-344 in patients with HER2-negative breast cancer.
"The ASCO Annual Meeting is an important event for MEI Pharma this year and we are excited to present promising updated data from both our ME-401 and ME-344 programs at the meeting next month," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Specifically with regard to the ME-401 program, the Phase 1b data demonstrating high efficacy rates across all patient groups with an adverse event profile consistent with other PI3K delta inhibitors, along with our recently announced financing, make us well positioned to pursue our plan to initiate a ME-401 registration study before year end."
Poster Presentations at ASCO 2018
Title: Initial results of a dose escalation study of a selective and structurally differentiated PI3Kδ inhibitor, ME-401, in relapsed/refractory (R/R) follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Date & Time: 6/4/2018, 1:15 PM-2:30 PM
Poster Discussion Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Author: Jacob Drobnyk Soumerai, M.D., Massachusetts General Hospital
Title: Abrogation of resistance against bevacizumab (Bev) by mitochondrial inhibition: A phase 0 randomized trial of Bev plus ME-344 or placebo in early HER2-negative breast cancer (HERNEBC).
Date & Time: 6/4/2018, 8:00 AM-11:30 AM
Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Author: Miguel Quintela-Fandino, M.D., Ph.D., Director of the Clinical Research Program, Centro Nacional De Investigaciones Oncologicas, Madrid, Spain.
Abstracts featured as part of the ASCO 2018 program may be found at: https://iplanner.asco.org/am2018/#/
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 CLL or follicular lymphoma, 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-sponsored study in combination with bevacizumab for the treatment of 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, Inc.
For further information: David A. Walsey, VP of IR and Corporate Communications, Tel: 858-369-7104, firstname.lastname@example.org, OR Jason I. Spark, Canale Communications for MEI, Tel: 619-849-6005, email@example.com