FDA Approves Investigational New Drug Application for Clinical Testing of Oncology Drug Candidate ME-344

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Marshall Edwards, Inc, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced that it has received approval from the FDA of its Investigational New Drug (IND) application for ME-344, the Company’s lead mitochondrial inhibitor. The Company is in the process of initiating a phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors.

The phase I clinical trial of ME-344 is being conducted in collaboration with the Sarah Cannon Research Institute. The open-label, dose-escalation trial will evaluate the safety and tolerability of intravenous ME-344 in patients with refractory solid tumors. In addition, the trial is designed to characterize its pharmacokinetic profile and describe any preliminary clinical antitumor activity observed. 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.

The trial is expected to enroll up to 24 patients at three sites. Additional information regarding the trial, including enrollment criteria and site information, is available on the National Institutes of Health clinical trials database at www.clinicaltrials.gov.

ME-344 is the Marshall Edwards’ lead mitochondrial inhibitor and an active metabolite of NV-128, a first-generation compound. In preclinical studies, ME-344 has demonstrated far superior antitumor activity against a broad range of human cancer cell lines compared to NV-128, including breast, colorectal, and ovarian cancers. ■




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