Marshall Edwards, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, has initiated a phase I clinical trial of its lead drug candidate ME-143 in patients with refractory solid tumors. The trial is being conducted in collaboration with the Sarah Cannon Research Institute in Nashville, Tennessee, following the approval of an Investigational New Drug (IND) application by the FDA last month.
This phase I dose-escalation trial will evaluate the safety and tolerability of intravenous ME-143 in patients with refractory solid tumors. In addition, the trial is designed to characterize the pharmacokinetic profile of intravenous ME-143 and describe any preliminary clinical anti-tumor activity observed. The open-label trial is expected to enroll up to 24 patients with final data collected by the second quarter of 2012.
"Together with the Sarah Cannon Research Institute, we will be obtaining important information regarding dosing, safety and potential efficacy of intravenous ME-143 over the next several months, which will inform the design of our randomized phase II clinical trials in combination with standard-of-care chemotherapy,” said Robert D. Mass, MD, chief medical officer of Marshall Edwards.