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.