SAN DIEGO, Nov. 1, 2018 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced that it will present data from three accepted abstracts related to MEI Pharma's clinical stage drug development programs at the 2018 ASH Annual Meeting to be held December 1-4, 2018 in San Diego.
Study investigators will present updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma and other indolent B-cell malignancies, as well as results from a preclinical study demonstrating that voruciclib and venetoclax synergistically induce apoptosis in acute myeloid leukemia (AML) cells in vitro. The third abstract will present data from the pracinostat program, being developed in partnership with Helsinn Healthcare, SA, and will highlight an interim analysis of pracinostat in an ongoing Phase 2 study evaluating patients with high/very high-risk myelodysplastic syndrome (MDS).
"Data reported at the ASH Annual Meeting this year continue to highlight the depth of our clinical pipeline and the progress across multiple programs, each with its own distinct mechanisms for targeting cancer biology," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Notably, the ME-401 data to be reported is supportive of our approach to evaluate both a continuous and intermittent dosing schedule in our Phase 2 study planned to start around year-end in an effort to maximize the utility of the candidate as both a single agent or in combination with other therapies."
Dr. Gold continued: "We also look forward to highlighting the preclinical data demonstrating that our CDK9 inhibitor candidate, voruciclib, synergistically enhances cancer cell death when combined with venetoclax in AML cells in vitro, adding to earlier data showing similar synergies in CLL and DLBCL preclinical models. These results are supportive of possible future studies evaluating voruciclib in combination with venetoclax in relapsed AML."
Poster Presentations at ASH 2018
Title: Preliminary Safety and Efficacy Results with an Intermittent Schedule of the PI3K delta Inhibitor ME-401 Alone or in Combination with Rituximab for B-Cell Malignancies
Date & Time: December 2, 2018, 6:00 p.m. - 8:00 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 115670
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
Author: Andrew D. Zelenetz, M.D., Ph.D., Medical Director, Quality Informatics at Memorial Sloan Kettering Cancer Center
Title: Voruciclib, an Oral, Selective CDK9 Inhibitor, Enhances Cell Death Induced by the Bcl-2 Selective Inhibitor Venetoclax in Acute Myeloid Leukemia
Date & Time: December 1, 2018, 6:15 p.m. - 8:15 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 118372
Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster I
Author: Daniel A. Luedtke, BS, Wayne State University School of Medicine, Cancer Biology Graduate Program
Title: Planned Interim Analysis of a Phase 2 Study Evaluating the Combination of Pracinostat, a Histone Deacetylase Inhibitor (HDACi), and Azacitidine in Patients with High/Very High-Risk Myelodysplastic Syndrome (MDS)
Date & Time: December 3, 2018, 6:00 p.m. - 8:00 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 112741
Session: 637. Myelodysplastic Syndromes—Clinical Studies: Poster III
Author: Michael Keng, M.D., University of Virginia School of Medicine, Assistant Professor
Abstracts featured as part of the ASH 2018 program may be found at: http://www.hematology.org/Annual-Meeting/Oral-Posters.aspx
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). 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.
Forward-Looking Statements
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.
