Marshall Edwards, Inc., an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced 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 US 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, PhD, 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 tumour cells in laboratory studies. In pre-clinical studies, ME-143 has demonstrated anti-tumour activity against a number of tumour 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.