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ME-344

Treatment for: Ovarian Cancer, Small Cell Lung Cancer

Marshall Edwards Submits Investigational New Drug Application for Oncology Drug Candidate ME-344

SAN DIEGO, March 06, 2012, 2012 /PRNewswire/ -- Marshall Edwards, Inc. , 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 rapid loss of cellular energy and leads to the inhibition of both mammalian target of rapamycin (mTOR1 and mTOR2) pathways. In April 2011, Ayesha Alvero, M.D., Department of Obstetrics, Gynecology and Reproductive Sciences at Yale University School of Medicine, presented data at the American Association for Cancer Research Annual Meeting from a pre-clinical study of NV-128 demonstrating its ability to induce mitochondrial instability, ultimately leading to cell death in otherwise chemotherapy-resistant ovarian cancer stem cells. These results were later published in the August 2011 issue of . In additional pre-clinical studies, ME-344 has demonstrated far superior anti-tumor activity against a broad range of human cancer cell lines compared to NV-128.

Marshall Edwards, Inc. is a San Diego-based oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism. The Company's lead drug candidates, ME-143 and ME-344, have been shown to interact with specific enzyme targets resulting in inhibition of tumor cell metabolism, a function critical for cancer cell survival. Marshall Edwards initiated a Phase I clinical trial of intravenous ME-143 in patients with solid refractory tumors in September 2011 and expects to collect final safety and pharmacokinetic data from the trial by June 2012. The Company submitted an Investigational New Drug application for ME-344 in March 2012 and plans to initiate a Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors following approval by the FDA.

Posted: March 2012

ME-344 FDA Approval History

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