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Marshall Edwards Announces FDA Approval of Investigational New Drug Application for Lead Candidate ME-143
Date:8/16/2011

SAN DIEGO, Aug. 16, 2011 /PRNewswire/ -- Marshall Edwards, Inc. (Nasdaq: MSHL), 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) 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 fir
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SOURCE Marshall Edwards, Inc.
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