SAN DIEGO, June 4, 2012 /PRNewswire/ -- Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced results from a Phase I clinical trial of its lead drug candidate ME-143 in patients with solid refractory tumors. The data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago today.
"We are encouraged by the results from this first-in-human study of ME-143," said presenter and co-investigator Carla Kurkjian, MD, University of Oklahoma Health Sciences Center. "ME-143 appears to be generally well tolerated with minimal toxicity as a single agent in heavily treated patients. We look forward to further studies of ME-143 in combination with cytotoxic therapies."
A copy of today's poster presentation, entitled "ME-143, a novel inhibitor of tumor-specific NADH oxidase (tNOX): Results from a first-in-human phase I study," is available at www.marshalledwardsinc.com.
The Phase I trial of ME-143 was initiated in September 2011 following the approval of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration. The open label trial was designed to evaluate the safety and tolerability of intravenous ME-143, the Company's next-generation NADH oxidase inhibitor, in patients with refractory solid tumors and characterize its pharmacokinetic profile. A total of 15 patients were enrolled in escalating dose cohorts of 2.5 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg. The median number of prior therapies was four. Stable disease was observed in one patient at more than 15 weeks, which is comparable to Phase I studies of Phenoxodiol, the Company's first-generation NADH oxidase inhibitor, in which stable disease was also the best response observed. ME-143 was generally well tolerated at all dose levels on a weekly dosing schedule and the maximum tolerated dose was defined as 20 mg/kg.
"We have achieved our main objective in this trial," said Robert Mass, M.D., Chief Medical Officer of Marshall Edwards, "specifically, to establish a recommended dose for the next phase of development with ME-143. With the exception of a serious infusion reaction in one patient at the highest dose level, ME-143 was generally well tolerated. In addition, the pharmacokinetic profile of intravenous ME-143 resulted in drug levels that were approximately 30 times higher than the exposure achieved in a Phase II trial of intravenous Phenoxodiol in combination with platinum-based chemotherapy in women with platinum-resistant ovarian cancer. These results enable us to better prepare for the first of our Phase II efficacy studies of ME-143 in combination with standard-of-care chemotherapy later this year."
ME-143 is Marshall Edwards' lead NADH oxidase inhibitor drug candidate. In pre-clinical studies, ME-143 demonstrated superior anti-tumor activity against a number of tumor cell lines compared to Phenoxodiol, the Company's first-generation NADH oxidase inhibitor, including breast, colorectal and ovarian. In addition to broad single-agent activity, ME-143 has also shown a far superior ability to enhance the cytotoxic effects of chemotherapy in pre-clinical studies as compared to Phenoxodiol. Marshall Edwards owns exclusive worldwide rights to ME-143. ME-143 is an investigational drug and has not been approved by the FDA for commercial distribution in the U.S. or other countries.
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 presented safety and pharmacokinetic data from a Phase I clinical trial of intravenous ME-143 in patients with solid refractory tumors at the American Society of Clinical Oncology Annual Meeting in June 2012 and plans to initiate a Phase II clinical trial of intravenous ME-143 in combination with chemotherapy by year-end. The Company received approval of its IND 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.
 Kelly et al. Phase II Evaluation of Phenoxodiol in Combination With Cisplatin or Paclitaxel in Women With Platinum/Taxane-Refractory/Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers. Int J Gynecol Cancer. 2011 May;21(4):633-9.
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