(ChemotherapyAdvisor) – San Diego-based pharmaceutical company Marshall Edwards, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for ME-344, the company’s lead mitochondrial inhibitor. A Phase 1 clinical trial of intravenous ME-344 in patients with solid refractory tumors is currently being initiated.

Data from a preclinical study of NV-128, the metabolic precursor of ME-344, demonstrated its ability to induce mitochondrial instability, ultimately leading to cell death in otherwise chemotherapy-resistant ovarian cancer stem cells. These data were presented at AACR 2011 and were later published in the August 2011 issue of Molecular Cancer Therapeutics. Data from additional preclinical studies demonstrated ME-344’s anti-tumor activity against a broad range of human cancer cell lines compared to NV-128, including breast, colorectal, and ovarian.

The Phase 1 clinical trial of ME-344, which is being conducted in collaboration with the Sarah Cannon Research Institute, is an open-label, dose-escalation trial that will evaluate the safety and tolerability of intravenous ME-344 in patients with refractory solid tumors. Characterization of ME-344’s pharmacokinetic profile will also be performed, and any preliminary clinical anti-tumor activity observed will be described, in Phase 1. In terms of the dosing schedule, 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, according to the company. The trial is expected to enroll up to 24 patients at three sites.

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