Marshall Edwards’ lead candidate ME-143 receives FDA approval
Marshall Edwards, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, has reported 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 FDA. The company plans to initiate a phase I clinical trial of intravenous ME-143.
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.