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Marshall Edwards Announces Data from Clinical Trial of ME-143 Selected for Presentation at ASCO Annual Meeting

Apr 3, 2012

San Diego – Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that data from a Phase I clinical trial of the Company’s lead drug candidate ME-143 has been selected for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held June 1-5, 2012, in Chicago. An abstract of the presentation, entitled “ME-143, a novel inhibitor of tumor-specific NADH oxidase (tNOX): Results from a first-in-human phase I study,” will be available online at www.asco.org approximately two weeks before the Annual Meeting.
 
“This represents an exciting opportunity to present the data from our trial of ME-143 to oncology thought leaders from around the world,” said Robert Mass, M.D., Chief Medical Officer of Marshall Edwards. “These data will be instrumental as we prepare for the first of our randomized Phase II clinical trials later this year. We are grateful for the ongoing commitment of the clinical investigators, trial coordinators and especially the patients who participated in this study.”

Marshall Edwards recently completed enrollment of the fourth cohort in the Phase I clinical trial of ME-143. The dose-escalation trial is evaluating the safety and tolerability of ME-143 in patients with refractory solid tumors. In addition, the trial is designed to characterize the pharmacokinetic profile of intravenous ME-143 and describe any preliminary clinical anti-tumor activity observed. The multi-center trial is being conducted in collaboration with the Sarah Cannon Research Institute.

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 submitted an Investigational New Drug application for ME-344 in March 2012 and plans to initiate a Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors immediately following approval by the FDA. 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.


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