SAN DIEGO, March 6, 2012 /PRNewswire/ -- Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate clinical testing for oncology drug candidate ME-344, the Company's lead mitochondrial inhibitor.
"I am extremely proud of our clinical operations and pre-clinical research teams in reaching this important milestone, less than seven months since our IND for ME-143 was approved by the FDA to begin clinical testing," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of Marshall Edwards. "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."
Marshall Edwards also announced that it has 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 to collect final safety and pharmacokinetic data from this trial by June.
"We continue to execute on the clinical development plan we set forth for our two most promising drug candidates," said Robert Mass, M.D., Chief Medical Officer of Marshall Edwards. "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."
Marshall Edwards owns exclusive worldwide rights to all of its drug candidates, including ME-143 and ME-344.
ME-344 is Marshall Edwards' lead mitochondrial inhibitor and an active metabolite of NV-128, a first-generation compound. Treatment of tumor cells with the Company's mitochondrial inhibitor compounds induces a rap
|SOURCE Marshall Edwards, Inc.|
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