Earlier today, Marshall Edwards, Inc. (Nasdaq: MSHL) announced the commencement of a Phase I clinical trial of the Company’s lead drug candidate ME-143 in patients with refractory solid tumors. Marshall Edwards is an oncology company aimed at the clinical development of novel therapeutics for cancer metabolism. The U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) last month, following which the trial has been initiated in partnership with the Sarah Cannon Research Institute in Nashville, Tennessee.
Intravenous ME-143 will be tested for its safety and tolerability in patients with refractory solid tumors through a Phase I, open-label, dose-escalation trial. The trial that is expected to enroll 24 patients is further designed to exemplify the drug’s pharmacokinetic profile and depict any preliminary clinical anti-tumor activity. Final data collection will be performed towards the second quarter of 2012.
Chief Medical Officer of Marshall Edwards, Robert D. Mass, MD said, “We are excited to begin treating patients with ME-143, a promising drug candidate that has demonstrated anti-tumor activity in pre-clinical studies. 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.”
About ME-143: Taken from Marshall Edwards’ NADH oxidase inhibitor program, ME-143 is the company’s chief oncology drug candidate. The proprietary isoflavone technology platform used to derive the drug has created several compounds exhibiting anti-proliferative activity against tumor cells in laboratory studies. The potent activity of ME-143 has been established in preclinical studies where the drug has been found to be effective against a number of tumor cell lines, including breast, colorectal, and ovarian. In pre-clinical studies, ME-143 has also exhibited its capability to augment cytotoxic chemotherapy effects in addition to its broad single-agent activity. The worldwide exclusivity to ME-143 rests with Marshall Edwards. The investigational drug has not yet received FDA marketing approval in the US or other countries.