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news.Marshall Edwards has announced dosing of first cohort of patients in a Phase I clinical trial of ME-344, a mitochondrial inhibitor drug candidate, in patients with refractory solid tumors.
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The trial evaluating the safety and tolerability of intravenous ME-344 in escalating dose cohorts of 1.2mg/kg, 2.5mg/kg, 5mg/kg, 10mg/kg and 20mg/kg, will enroll 24 patients into five cohorts.
Marshall Edwards chief medical officer Robert Mass said, "ME-344 is a novel compound that showed compelling anti-tumor activity in pre-clinical studies."
In the dose escalation trial, patients 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.
The company expects to report final safety and pharmacokinetic data in the first half of 2013.