The US Patent and Trademark Office (USPTO) has issued a new method of use patent, US Patent No. 8,084,628, covering a number of the Marshall Edwards' mitochondrial inhibitor compounds, including lead drug candidate ME-344, for the treatment of cancer or a tumour mass. The patent is expected to provide protection until September 2025.

Treatment of tumour 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. The Company has completed the necessary pre-clinical animal toxicity studies to support submission of an Investigational New Drug (IND) application for ME-344 this quarter, and expects to initiate a phase I clinical trial of intravenous ME-344 shortly thereafter.

“Given the increased interest in oncology compounds that can impact both the mTOR1 and mTOR2 pathways, we are particularly pleased to receive patent coverage for the use of ME-344 in cancer,” said Daniel P Gold, PhD, president and chief executive officer of Marshall Edwards. “This new patent reaffirms our ongoing commitment to expanding and strengthening our intellectual property portfolio while adding to the value of our drug development pipeline. A strong patent estate is essential to the commercial potential of our drug candidates and should be recognized by potential partners.”