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news.Marshall Edwards has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to initiate clinical testing for oncology drug candidate ME-344, the company's mitochondrial inhibitor.
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Marshall Edwards is an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism.
Marshall Edwards president and chief executive officer Daniel Gold expressed satisfaction on clinical operations and pre-clinical research teams in reaching this important milestone, less than seven months since IND for ME-143 was approved by the FDA to begin clinical testing.
"We are prepared to initiate a Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors immediately following approval by the FDA," Gold said.
Marshall Edwards has also commenced dosing of the fourth cohort in its Phase I clinical trial of intravenous ME-143 in patients with solid refractory tumors.
The Company expects that by June it will collect final safety and pharmacokinetic data from this trial.
Marshall Edwards chief medical officer Robert Mass said: "Now, as we await approval of our IND for ME-344 and near the completion of enrollment in our Phase I clinical trial of ME-143, we are diligently preparing for our Phase II trials."