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 (NYSE: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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