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Marshall Edwards, Inc. (MSHL) Announces FDA Approval of Investigational New Drug Application for Lead Candidate ME-143


8/16/2011 7:15:04 AM

SAN DIEGO, Aug. 16, 2011 /PRNewswire/ -- Marshall Edwards, Inc. (Nasdaq:MSHL - News), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that its Investigational New Drug (IND) application for ME-143 (formerly NV-143), the Company's lead NADH oxidase inhibitor, has been approved by the U.S. Food and Drug Administration (FDA). The Company plans to initiate a Phase I clinical trial of intravenous ME-143 by September.

"This IND represents a significant milestone for Marshall Edwards and, more importantly, a critical step forward in the development of a drug candidate that we believe has the potential to significantly improve the treatment of patients with cancer," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of Marshall Edwards. "We are excited to get back into the clinic and are working diligently to initiate a Phase I trial of ME-143 as soon as possible."

ME-143 was derived from an isoflavone technology platform that has generated a number of compounds with anti-proliferative activity against tumor cells in laboratory studies. In pre-clinical studies, ME-143 has demonstrated anti-tumor activity against a number of tumor cell lines, including breast, colorectal and ovarian. In addition to broad single-agent activity, ME-143 has also shown an ability to enhance the cytotoxic effects of chemotherapy in pre-clinical studies.

Marshall Edwards owns exclusive worldwide rights to ME-143.

About Marshall Edwards

Marshall Edwards, Inc. (Nasdaq:MSHL - News) 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 (formerly NV-143). The second is a mitochondrial inhibitor program that includes lead candidate ME-344 (formerly NV-344). The Company expects to initiate a Phase I clinical trial of intravenous ME-143 by September 2011 and submit an Investigational New Drug application for ME-344 by 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.



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