Marshall Edwards Issued New Method of Use Patent for Lead Oncology Drug Candidate ME-344 SAN DIEGO, Jan. 3, 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 U.S. Patent and Trademark Office has issued a new method of use patent, U.S. Patent No. 8,084,628, covering a number of the Company's mitochondrial inhibitor compounds, including lead drug candidate ME-344, for the treatment of cancer or a tumor mass. The patent is expected to provide protection until September 2025. Treatment of tumor cells with the Company's mitochondrial inhibitor compounds induces a rapid loss of cellular energy and leads to the inhibition of both mammalian target of rapamycin (mTOR1 and mTOR2) pathways. The Company has completed the necessary pre-clinical animal toxicity studies to support submission of an Investigational New Drug (IND) application for ME-344 this quarter, and expects to initiate a Phase I clinical trial of intravenous ME-344 shortly thereafter. "Given the increased interest in oncology compounds that can impact both the mTOR1 and mTOR2 pathways, we are particularly pleased to receive patent coverage for the use of ME-344 in cancer," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of Marshall Edwards. This new patent reaffirms our ongoing commitment to expanding and strengthening our intellectual property portfolio while adding to the value of our drug development pipeline. A strong patent estate is essential to the commercial potential of our drug candidates and should be recognized by potential partners. About Marshall Edwards Marshall Edwards, Inc. (Nasdaq: MSHL) is a San Diego-based oncology company focused on the clinical development of novel anti-cancer therapeutics. The Company's lead programs focus on two families of small molecules that result in the inhibition of tumor cell metabolism. The first and most advanced is a NADH oxidase inhibitor program that includes lead candidate ME-143. The Company initiated a Phase I clinical trial of intravenous ME-143 in patients with solid refractory tumors in September 2011 and expects final data from the trial by the second quarter of 2012. The second program is a family of mitochondrial inhibitors that includes lead candidate ME-344. The Company has completed the necessary pre-clinical animal toxicity studies to support submission of an Investigational New Drug (IND) application for ME-344 in the first quarter of 2012. 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. SOURCE Marshall Edwards, Inc.