The US Food and Drug Administration (FDA) has approved Marshall Edwards', an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, Investigational New Drug (IND) application for ME-344, the company’s lead mitochondrial inhibitor. The company is now in the process of initiating a phase I clinical trial of intravenous ME-344 in patients with solid refractory tumours.

“With this important milestone, we have now successfully advanced our two most promising oncology drug candidates into the clinic,” said Daniel P. Gold, Ph.D., president and chief executive officer of Marshall Edwards. “As we near the completion of our phase I clinical trial of ME-143 and prepare for its next phase of development, we are excited to initiate our first human study of ME-344. We believe ME-344 is a novel compound that has the potential to significantly improve treatment outcomes for patients with cancer, but first it is important to confirm its safety and tolerability in patients while establishing an optimal dose for future trials.”

The phase I clinical trial of ME-344 is being conducted in collaboration with the Sarah Cannon Research Institute. The open-label, dose-escalation trial will evaluate the safety and tolerability of intravenous ME-344 in patients with refractory solid tumours. In addition, the trial is designed to characterize its pharmacokinetic profile and describe any preliminary clinical anti-tumour activity observed. Patients will be administered intravenous infusions of ME-344 once weekly for three weeks and, after safety assessment, may continue weekly dosing if a clinical benefit is determined. The trial is expected to enroll up to 24 patients at three sites.

ME-344 is the Marshall Edwards’ lead mitochondrial inhibitor and an active metabolite of NV-128, a first-generation compound. In April 2011, Ayesha Alvero, M.D., Department of Obstetrics, Gynecology and Reproductive Sciences at Yale University School of Medicine, presented data at the American Association for Cancer Research Annual Meeting from a pre-clinical study of NV-128 demonstrating its ability to induce mitochondrial instability, ultimately leading to cell death in otherwise chemotherapy-resistant ovarian cancer stem cells. These results were later published in the August 2011 issue of Molecular Cancer Therapeutics. In additional pre-clinical studies, ME-344 has demonstrated far superior anti-tumour activity against a broad range of human cancer cell lines compared to NV-128, including breast, colorectal and ovarian. Marshall Edwards owns exclusive worldwide rights to all of its drug candidates, including ME-344.