, May 5, 2014
/PRNewswire/ -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that the first patient has been dosed in a Phase Ib clinical study of its investigational mitochondrial inhibitor drug candidate ME-344 in combination with Hycamtin®
(topotecan) in patients with solid tumors, including small cell lung and ovarian cancers. The open-label study is expected to enroll up to 64 patients with preliminary data anticipated by the first quarter of 2015.
"ME-344 is an exciting drug candidate with a unique mechanism of action," said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. "In pre-clinical studies, ME-344 showed broad and potent anti-tumor activity, including a model of chemotherapy-resistant ovarian cancer stem cells. Our first-in-human clinical study demonstrated evidence of single-agent activity, including a sustained partial response in a heavily pre-treated patient with small cell lung cancer. We are excited to initiate this second clinical study in order to better assess the potential of ME-344 in combination with chemotherapy."
In October 2013, results from a Phase I clinical study of ME-344 were announced showing preliminary evidence of single-agent activity in patients with refractory solid tumors, including eight of 21 evaluable patients (38%) who achieved stable disease or better. Notably, one patient with small cell lung cancer achieved a confirmed partial response (PR) and still remains on study after more than 89 weeks. ME-344 was generally well tolerated in the study at doses equal to or less than 10 mg/kg delivered on a weekly schedule for extended durations. Dose limiting toxicities were observed at both the 15 and 20 mg/kg dose levels, consisting primarily of Grade 3 peripheral neuropathy.
The Phase Ib study now underway is evaluating the safety and tolerability of intravenous ME-344 in combination with Hycamtin, a chemotherapy approved by the U.S. Food & Drug Administration for the treatment of small cell lung, ovarian and cervical cancers. The initial stage of the study will establish the maximum tolerated dose (MTD) of ME-344 in combination with Hycamtin in up to 24 patients. Once the MTD has been determined, the study will enroll an additional 40 patients into two cohorts: relapsed/refractory small cell lung cancer and platinum-refractory ovarian cancer.
The open-label study is being conducted in collaboration with the Sarah Cannon Research Institute at the University of Oklahoma in Oklahoma City and Tennessee Oncology in Nashville. Additional information, including enrollment criteria, is available on the U.S. National Institutes of Health clinical trials database at www.clinicaltrials.gov.
ME-344 is MEI Pharma's mitochondrial inhibitor drug candidate derived from the Company's isoflavone-based technology platform. In preclinical studies, ME-344 has been shown to cause caspase-independent cell death in multiple human tumor cell lines, including ovarian cancer stem cells, by interfering with mitochondrial energy generation. In April 2013, Ayesha Alvero, MD, Yale University School of Medicine, presented data at the American Association for Cancer Research 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.
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 histone deacetylase (HDAC) inhibitor currently being developed for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Results from a pilot Phase II clinical study of Pracinostat in combination with Vidaza in patients with advanced MDS showed an overall response rate of 90% (nine of 10). MEI Pharma is also developing ME-344, a mitochondrial inhibitor that has shown preliminary evidence of single-agent activity in a first-in-human clinical study in patients with refractory solid tumors, including eight of 21 evaluable patients (38%) who achieved stable disease or better. 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.
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