Marshall Edwards Announces FDA Approval of Investigational New Drug Application for Lead Candidate ME-143

Marshall Edwards, Inc. MSHL announced today that its Investigational New Drug 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."