SAN DIEGO, May 29, 2012 /PRNewswire/ -- Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that the first cohort of patients has been dosed in a Phase I clinical trial of ME-344, the Company's lead mitochondrial inhibitor drug candidate, in patients with refractory solid tumors. The dose escalation trial is expected to enroll up to 24 patients in up to five cohorts with final safety and pharmacokinetic data expected in the first half of 2013.
"We are very pleased to see the excitement surrounding our initial clinical trial of ME-344, with the first cohort of patients now well underway just a month after our Investigational New Drug application was approved by the FDA," said Robert D. Mass, MD, Chief Medical Officer of Marshall Edwards. "ME-344 is a novel compound that showed compelling anti-tumor activity in pre-clinical studies. Now we look forward to gathering valuable clinical data in the months ahead, all of which will help to optimize the design of our Phase II efficacy studies."
The Phase I clinical trial is evaluating the safety and tolerability of intravenous ME-344 in escalating dose cohorts of 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg. In addition, the trial is designed to characterize the pharmacokinetic profile of ME-344 and describe any preliminary clinical anti-tumor activity observed. Patients in the trial are administered intravenous infusions of ME-344 once weekly for three weeks and, after safety assessment, may continue weekly dosing if a clinical benefit is determined.
The open-label trial is being conducted in collaboration with the Sarah Cannon Research Institute at three sites: Florida Cancer Specialists in Sarasota, University of Oklahoma in Oklahoma City and Tennessee Oncology in Nashville. Additional information regarding the trial, including enrollment criteria, is available on the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.About ME-344 ME-344 is Marshall Edwards' lead mitochondrial inhibitor and an active metabolite of NV-128, the Company's 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 has demonstrated far superior anti-tumor activity against a broad range of human cancer cell lines compared to NV-128, including breast, colorectal and ovarian. Marshall Edwards owns exclusive worldwide rights to all of its drug candidates, including ME-344. About Marshall Edwards Marshall Edwards, Inc. (Nasdaq: MSHL) is a San Diego-based oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism. The Company's lead drug candidates, ME-143 and ME-344, have been shown in laboratory studies to interact with specific enzyme targets resulting in inhibition of tumor cell metabolism, a function critical for cancer cell survival. Marshall Edwards initiated a Phase I clinical trial of intravenous ME-143 in patients with solid refractory tumors in September 2011 and plans to present safety and pharmacokinetic data from the trial at the American Society of Clinical Oncology Annual Meeting in June 2012. The Company received approval of its Investigational New Drug application for ME-344 in April 2012 and initiated a Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors shortly thereafter. For more information, please visit www.marshalledwardsinc.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.