MEI Pharma Announces Topline Data From Phase I Clinical Trial Of Mitochondrial Inhibitor Drug Candidate ME-344
Tumor Response Observed in Patient with Refractory Small Cell Lung Cancer
Oct 10, 2013
SAN DIEGO, Oct. 10, 2013 /PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced that data from the ongoing Phase I clinical trial of its mitochondrial inhibitor drug candidate ME-344 in patients with refractory solid tumors will be presented at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.
As reported in the abstract of the presentation, eight of the 23 patients evaluable for efficacy (35%) achieved disease control, including one confirmed partial response (PR) in a patient with refractory small cell lung cancer (duration 52+ weeks) and seven patients with prolonged stable disease (SD) ranging from 8 to 40+ weeks. The maximum tolerated dose was established at 10 mg/kg delivered on a weekly schedule. Dose limiting toxicity of Grade 3 neuropathy was observed at 15 mg/kg and 20 mg/kg.
Detailed results from the trial will be presented on Sunday, October 20, 2013 at 12:30 p.m. Eastern time from Exhibit Hall C-D of the Hynes Convention Center. The abstract, entitled "ME-344, a novel mitochondrial oxygenase inhibitor: Results from a first-in-human Phase I study," is now available online at www.aacr.org/home/scientists/meetings--workshops/molecular-targets-and-cancer-therapeutics.aspx.
ME-344 is MEI Pharma's next-generation mitochondrial inhibitor drug candidate and an active metabolite of NV-128, the Company's first-generation compound. In April 2013, 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 (AACR) Annual Meeting showing the ability of ME-344 to decrease tumor burden and delay recurrence in a pre-clinical in vivo model of recurrent epithelial ovarian cancer, the most lethal of all gynecologic malignancies. In April 2011, Dr. Alvero also presented data at AACR 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.
MEI Pharma owns exclusive worldwide rights to 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 HDAC inhibitor being developed for advanced hematologic diseases, such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). The Company initiated a randomized, placebo-controlled Phase II trial of Pracinostat in combination with Vidaza (azacitidine) in patients with previously untreated MDS in June 2013. An open-label Phase II trial of Pracinostat in combination with Vidaza in elderly patients with AML who are unsuitable for induction therapy is expected to initiate in the fall of 2013. In addition, MEI Pharma is developing two drug candidates derived from its isoflavone-based technology platform, ME-344 and ME-143. In September 2013, the Company further expanded its pipeline of drug candidates with the acquisition of PWT143, a highly selective PI3-kinase delta inhibitor. 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.
SOURCE MEI Pharma, Inc.
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