Healthcare Industry News: intended use
News Release - December 12, 2006
Marshall Edwards, Inc. Announces Initial Trial Sites, Principle Investigator for Phase III OVATURE Trial for PhenoxodiolWASHINGTON, Dec. 12 (HSMN NewsFeed) -- Marshall Edwards, Inc. today announced that the pivotal trial for its lead investigational anti-cancer drug phenoxodiol is on schedule and that trial sites have been established on three continents. The comments were made at the annual shareholder meeting held here today.
In the United States, negotiations have begun with 9 trial sites. Yale University School of Medicine and US Oncology have submitted the protocol to their respective institutional review boards and are awaiting clearance to begin enrollment. US Oncology has cancer treatment centers in over 30 states. The Company is negotiating with 20 sites in Europe, and has already signed 5 sites in Australia for the trial.
The Company also announced that Thomas Rutherford, M.D. Associate Professor of Gynecology and Reproductive Sciences at Yale University School of Medicine, will be a principal investigator for the OVATURE trial. The OVATURE trial is a multi-center multi-national ovarian cancer study to confirm the effectiveness of phenoxodiol in resensitizing patients to chemotherapy. The total number of patients to be treated in this pivotal study is 470, with half to be on a treatment regime of phenoxodiol and the chemotherapeutic drug carboplatin, and half on a placebo and carboplatin.
The primary outcome of the trial is the assessment of the relative time it takes for the ovarian cancer to progress. An analysis of interim results will be possible after 95 patients have progressed with their disease.
The trial is being run under arrangements approved by the US Food and Drug Administration (FDA) known as a Special Protocol Assessment (SPA). This provides for the interim analysis of the data, which if significant can be used to support a request for grant of marketing approval.
Ovarian cancer is the most lethal gynecological malignancy and the fifth leading cause of cancer-related death in women in the United States. The high mortality rate is due mainly to the inability to detect early disease with approximately 80 percent of patients being diagnosed in advanced stage of disease.
The Company also announced today that it will not be extending the expiration date of its existing warrants that are scheduled to expire on December 16, 2006.
Phenoxodiol is an investigational drug and, as such, is not commercially available. Phenoxodiol is a novel-acting drug that inhibits key pro-survival signaling pathways operating via sphingosine-1-phosphate and Akt. Inhibition of these pathways leads to prevention of phosphorylation of key anti-apoptotic proteins such as XIAP. Loss of activity of these proteins restores the ability of chemoresistant tumor cells to undergo apoptosis in response to chemotherapy. The putative molecular target for phenoxodiol is a tumor- specific protein, accounting for the highly selective nature of the drug.
About Marshall Edwards, Inc.
Marshall Edwards, Inc. (Nasdaq: MSHL ) has licensed rights from Novogen Limited (Nasdaq: NVGN ) to bring three oncology drugs -- phenoxodiol, NV-196 and NV-143 -- to market globally. Marshall Edwards, Inc. is majority owned by Novogen, an Australian biotechnology company that is specializing in the development of therapeutics based on a flavonoid technology platform. Novogen, based in Sydney, Australia, is developing a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases. More information on phenoxodiol and on the Novogen group of companies can be found at http://www.marshalledwardsinc.com and http://www.novogen.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 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
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