Nov 19, 2012
San Diego – MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that its lead mitochondrial inhibitor drug candidate, ME-344, has been named one of the Top 10 Most Licensable Oncology Products to Watch for 2012 by Elsevier Business Intelligence and Campbell Alliance.
“We are honored to have ME-344 considered among the most attractive oncology opportunities in the industry,” said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. “We believe ME-344 is a novel compound with a unique mechanism of action that has the potential to complement standards-of-care and significantly improve treatment outcomes for patients with cancer. Our Phase I clinical trial of ME-344 in patients with solid refractory tumors is nearing completion of enrollment and we look forward to reporting its results, along with our plans for its next phase of clinical development, during the second quarter of 2013.”
Projects were selected using a set of judging criteria that included unmet medical need, market potential, diversity of indications, strong science, multi-level partnering opportunities (biotech and pharma), potential for new opportunities beyond initial indications and corporate stability. Selected projects will be presented at the Windhover Therapeutic Area Partnerships conference in Boston on November 29, 2012. More information can be found at www.tapartnerships.com.
ME-344 is MEI Pharma’s lead mitochondrial inhibitor and an active metabolite of NV-128, its first-generation compound. In April 2011, Ayesha Alvero, M.D., Department of Obstetrics, Gynecology and Reproductive Sciences at Yale University School of Medicine, presented data at the American Association for Cancer Research Annual Meeting from a pre-clinical study of NV-128 demonstrating its ability to induce mitochondrial instability, ultimately leading to cell death in otherwise chemotherapy-resistant ovarian cancer stem cells. These results were later published in the August 2011 issue of Molecular Cancer Therapeutics. In additional pre-clinical studies, ME-344 demonstrated superior anti-tumor activity against a broad range of human cancer cell lines compared to NV-128
A Phase I trial of intravenous ME-344 in patients with solid refractory tumors is ongoing. The trial is evaluating the safety and tolerability of intravenous ME-344 in five escalating dose cohorts and is expected to enroll up to 24 patients. Dosing of the fourth cohort (10 mg/kg) is nearly complete; no dose-limiting toxicities have been observed to date. Final safety and pharmacokinetic data is expected in the second quarter of 2013.
MEI Pharma owns exclusive worldwide rights to all of its drug candidates, including ME-344.
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 lead drug candidate is Pracinostat, a potential best-in-class, oral histone deacetylase (HDAC) inhibitor, which has been tested in multiple Phase I and pilot Phase II clinical trials, including advanced hematologic malignancies such as myelodysplastic syndrome (MDS), acute myeloid leukemia and myelofibrosis. The Company expects to initiate a randomized Phase II trial of Pracinostat in combination with azacitidine in patients with MDS by the second quarter of 2013. In addition, MEI Pharma is developing two drug candidates derived from its isoflavone-based technology platform, ME-143 and ME-344. For more information, go to www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials 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.