Monday, June 4, 2012

Marshall Edwards, Inc. (MSHL) Reveals Clinical Trial Results for Oncology Drug

Marshall Edwards is an 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 shown in laboratory studies to interact with specific enzyme targets resulting in inhibition of tumor cell metabolism.

The company reported results from a Phase I clinical trial of its ME-143 drug candidate in patients with solid refractory tumors. Marshall Edwards stated that “ME-143 appears to be generally well tolerated with minimal toxicity …in heavily treated patients.” The trial began in September 2011 after FDA approval of an Investigational New Drug (IND) application. A total of 15 patients with solid tumors were enrolled in escalating weekly dose cohorts of 2.5mg/kg, 5mg/kg, 10mg/kg and 20mg/kg.

The median number of prior therapies was four. Stable disease was observed in one patient at more than 15 weeks. This result is comparable to Phase I studies of Phenooxodiol, the company’s first generation NADH oxidase inhibitor, in which stable disease was also the best response observed during the study. The study was a success in that it achieved the main objective of establishing a recommended dose for the next phase of development and also set the maximum dosage at 20mg/kg.

Marshall Edwards is now looking forward to further studies of ME-143 in combination with cytotoxic therapies. The company is preparing for the first of its Phase II efficacy studies of the drug in combination with standard-of-care chemotherapy later this year.

For additional information about Marshall Edwards and its oncology drug candidates, please visit the company’s website at www.marshalledwardsinc.com

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