Marshall Edwards Announces First Patient Dosed in Phase I Clinical Trial of Lead Oncology Drug Candidate ME-143
Company to Host Conference Call on Thursday, September 29
Sep 19, 2011
San Diego – September 19, 2011 – Marshall Edwards, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that the first patient was dosed in the Company’s Phase I clinical trial of its lead drug candidate ME-143 in patients with refractory solid tumors. The trial, conducted in collaboration with the Sarah Cannon Research Institute, is expected to enroll up to 24 patients with final data collected by the second quarter of 2012.
Fiscal Year End Conference Call
Marshall Edwards also announced that its management team will host a conference call with simultaneous webcast on Thursday, September 29, 2011, beginning at 5:00 p.m. Eastern time. Daniel P. Gold, Ph.D., President and Chief Executive Officer, will present an overview of the Company; Robert Mass, MD, Chief Medical Officer, will discuss the Company’s lead oncology drug candidates, including an update on the Phase I clinical trial of ME-143; and Thomas Zech, Chief Financial Officer, will provide a summary of the Company’s fiscal year ended June 30, 2011 financial results.
To access the live call, please dial 866-800-8652 (toll-free) or 617-614-2705 (international), participant passcode 14784577. A replay of the call will be available approximately two hours after the conclusion of the call. To access the replay, please dial 888-286-8010 (toll-free) or 617-801-6888 (international), passcode 99793585. The conference call will also be webcast live and can be accessed at www.marshalledwardsinc.com/investor. Please connect several minutes prior to the start of the webcast to ensure adequate time for any software downloads that may be required.
About the Phase I Clinical Trial of ME-143
The Phase I trial of ME-143 was initiated earlier this month following the approval of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) in August. The open-label, dose-escalation trial is evaluating the safety and tolerability of intravenous ME-143 in patients with refractory solid tumors. In addition, the trial is designed to characterize the pharmacokinetic profile of intravenous ME-143 and describe any preliminary clinical anti-tumor activity observed. Additional information regarding this 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.
ME-143 is the lead oncology drug candidate from Marshall Edwards’ NADH oxidase inhibitor program. It was derived from a proprietary isoflavone technology platform that has generated a number of compounds with anti-proliferative activity against tumor cells in laboratory studies. In pre-clinical studies, ME-143 has demonstrated potent activity against a number of tumor cell lines, including breast, colorectal and ovarian. In addition to broad single-agent activity, ME-143 has also shown an ability to enhance the cytotoxic effects of chemotherapy in pre-clinical studies. Marshall Edwards owns exclusive worldwide rights to ME-143. ME-143 is an investigational drug and has not been approved by the FDA for commercial distribution in the U.S. or other countries.
About Marshall Edwards
Marshall Edwards, Inc. (Nasdaq: MSHL) is a San Diego-based oncology company focused on the clinical development of novel anti-cancer therapeutics. The Company’s lead programs focus on two families of small molecules that result in the inhibition of tumor cell metabolism. The first and most advanced is a NADH oxidase inhibitor program that includes lead candidate ME-143. The second is a mitochondrial inhibitor program that includes lead candidate ME-344. The Company initiated a Phase I clinical trial of intravenous ME-143 in September 2011 and expects to submit an IND application for ME-344 by the first quarter of 2012. 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.