Marshall Edwards presents results from clinical trial of lead oncology drug candidate ME-143 (MEI Pharma, ASCO 2012) - Jun 4, 2012 - P1, N=15; Study ID ME-143-001; Marshall Edwards announced results from a P1 clinical trial of its lead drug candidate ME-143 in patients with solid refractory tumors; The data were presented at the ASCO Annual Meeting in Chicago; 15 pts were enrolled in escalating dose cohorts of 2.5 mg/kg, 5 mg/kg, 10 mg/kg & 20 mg/kg; SD was observed in one pt at more than 15 weeks, which is comparable to P1 studies of phenoxodiol, the Company's first-generation NADH oxidase inhibitor, in which SD was also the best response observed; Anticipated P2 efficacy studies of ME-143 in combination with SOC chemotherapy later this year
Anticipated new P2 trial • P1 data • Oncology
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Data Presented at the American Society of Clinical Oncology Annual Meeting
San Diego – Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced results from a Phase I clinical trial of its lead drug candidate ME-143 in patients with solid refractory tumors. The data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago today.
“We are encouraged by the results from this first-in-human study of ME-143,” said presenter and co-investigator Carla Kurkjian, MD, University of Oklahoma Health Sciences Center. “ME-143 appears to be generally well tolerated with minimal toxicity as a single agent in heavily treated patients. We look forward to further studies of ME-143 in combination with cytotoxic therapies.”
A copy of today’s poster presentation, entitled “ME-143, a novel inhibitor of tumor-specific NADH oxidase (tNOX): Results from a first-in-human phase I study,” is available at www.marshalledwardsinc.com.
The Phase I trial of ME-143 was initiated in September 2011 following the approval of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration. The open label trial was designed to evaluate the safety and tolerability of intravenous ME-143, the Company’s next-generation NADH oxidase inhibitor, in patients with refractory solid tumors and characterize its pharmacokinetic profile. A total of 15 patients were enrolled in escalating dose cohorts of 2.5 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg. The median number of prior therapies was four. Stable disease was observed in one patient at more than 15 weeks, which is comparable to Phase I studies of Phenoxodiol, the Company’s first-generation NADH oxidase inhibitor, in which stable disease was also the best response observed. ME-143 was generally well tolerated at all dose levels on a weekly dosing schedule and the maximum tolerated dose was defined as 20 mg/kg.
"We have achieved our main objective in this trial,” said Robert Mass, M.D., Chief Medical Officer of Marshall Edwards, “specifically, to establish a recommended dose for the next phase of development with ME-143. With the exception of a serious infusion reaction in one patient at the highest dose level, ME-143 was generally well tolerated. In addition, the pharmacokinetic profile of intravenous ME-143 resulted in drug levels that were approximately 30 times higher than the exposure achieved in a Phase II trial of intravenous Phenoxodiol in combination with platinum-based chemotherapy in women with platinum-resistant ovarian cancer[1]. These results enable us to better prepare for the first of our Phase II efficacy studies of ME-143 in combination with standard-of-care chemotherapy later this year.”
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