Marshall Edwards initiates ME-344 Phase I trial in solid tumors

Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that the first cohort of patients has been dosed in a Phase I clinical trial of ME-344, the Company's lead mitochondrial inhibitor drug candidate, in patients with refractory solid tumors. The dose escalation trial is expected to enroll up to 24 patients in up to five cohorts with final safety and pharmacokinetic data expected in the first half of 2013.

"We are very pleased to see the excitement surrounding our initial clinical trial of ME-344, with the first cohort of patients now well underway just a month after our Investigational New Drug application was approved by the FDA," said Robert D. Mass, MD, Chief Medical Officer of Marshall Edwards. "ME-344 is a novel compound that showed compelling anti-tumor activity in pre-clinical studies. Now we look forward to gathering valuable clinical data in the months ahead, all of which will help to optimize the design of our Phase II efficacy studies."

The Phase I clinical trial is evaluating the safety and tolerability of intravenous ME-344 in escalating dose cohorts of 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg. In addition, the trial is designed to characterize the pharmacokinetic profile of ME-344 and describe any preliminary clinical anti-tumor activity observed. Patients in the trial are 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.