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Marshall Edwards, Inc. (MSHL) Receives FDA Approval of Investigational New Drug Application for Clinical Testing of Oncology Drug Candidate ME-344


4/10/2012 7:49:11 AM

SAN DIEGO, April 10, 2012 /PRNewswire/ -- Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that it has received approval from the U.S Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for ME-344, the Company's lead mitochondrial inhibitor. The Company is now in the process of initiating a Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors.

"With this important milestone, we have now successfully advanced our two most promising oncology drug candidates into the clinic," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of Marshall Edwards. "As we near the completion of our Phase I clinical trial of ME-143 and prepare for its next phase of development, we are excited to initiate our first human study of ME-344. We believe ME-344 is a novel compound that has the potential to significantly improve treatment outcomes for patients with cancer, but first it is important to confirm its safety and tolerability in patients while establishing an optimal dose for future trials."

The Phase I clinical trial of ME-344 is being conducted in collaboration with the Sarah Cannon Research Institute. The open-label, dose-escalation trial will evaluate the safety and tolerability of intravenous ME-344 in patients with refractory solid tumors. In addition, the trial is designed to characterize its pharmacokinetic profile and describe any preliminary clinical anti-tumor activity observed. Patients will be administered intravenous infusions of ME-344 once weekly for three weeks and, after safety assessment, may continue weekly dosing if a clinical benefit is determined. The trial is expected to enroll up to 24 patients at three sites. Additional information regarding the trial, including enrollment criteria and site information, is available on the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.

About ME-344

ME-344 is the Company's lead mitochondrial inhibitor and an active metabolite of NV-128, a first-generation compound. 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 Molecular Cancer Therapeutics. 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, including breast, colorectal and ovarian. Marshall Edwards owns exclusive worldwide rights to all of its drug candidates, including ME-344.

About Marshall Edwards

Marshall Edwards, Inc. (Nasdaq: MSHL) 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 in laboratory studies 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 plans to present safety and pharmacokinetic data from the trial at the American Society of Clinical Oncology Annual Meeting in June 2012. The Company received approval of its Investigational New Drug application for ME-344 in April 2012 and is in the process of initiating a Phase I clinical trial of intravenous ME-344 in patients with solid refractory tumors. For more information, please visit www.marshalledwardsinc.com.

Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

SOURCE Marshall Edwards, Inc.


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