Marshall Edwards, Inc. Announces Publication of Phase II Clinical Trial Results Highlighting Activity of Intravenous Phenoxodiol
SAN DIEGO, March 21, 2011 /PRNewswire/ -- Marshall Edwards, Inc.(Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today the publication of results from a Phase II clinical trial of intravenous Phenoxodiol in combination with cisplatin in women with platinum-resistant ovarian cancer. The publication is now available on the International Journal of Gynecological Cancer website and scheduled to print in the May issue of the journal.
The study, conducted at Yale-New Haven Hospital, showed that the combination of intravenous Phenoxodiol, a novel NADH oxidase inhibitor, with cisplatin, a platinum-based chemotherapy, was well tolerated and resulted in an overall response rate of 19% (3 out of 16) among ovarian cancer patients previously resistant to platinum. Response rate in this study was defined as the percentage of patients whose tumor demonstrated a radiologically confirmed reduction or disappearance after treatment. An abstract can be found at www.marshalledwardsinc.com/our-programs/scientific-publications that describes more information on the trial results.
"These results suggest that the combination of intravenous Phenoxodiol with cisplatin has a good safety profile and may be capable of reversing resistance to platinum-based chemotherapy," said lead author Michael G. Kelly, MD, a gynecologic oncologist at Tufts Medical Center and former fellow at Yale University School of Medicine." This study provides early clinical proof-of-concept for the combination of NADH oxidase inhibitors with standard-of-care chemotherapy and lays the groundwork for the development of more potent next-generation compounds."
To date, Phenoxodiol, an investigational drug, has been introduced into more than 400 patients in multiple clinical trials via oral or intravenous routes and has been well tolerated. Marshall Edwards has identified a next-generation compound called NV-143 that in laboratory studies has demonstrated significantly more activity than Phenoxodiol against a broad range of tumor cell lines. In addition to being more active as a single agent, NV-143 appears to be superior in its ability to synergize with platinum-based chemotherapy in pre-clinical studies. As a result, the Company plans to initiate a Phase I clinical trial of intravenous NV-143 later this year, followed immediately thereafter by randomized Phase II trials in combination with chemotherapy.
"These published results combined with data from previous studies reinforce our conclusion that intravenous administration is the optimal route of delivery for this class of drugs and give us added confidence moving forward as we develop our next-generation compound NV-143 for the clinic," said Robert D. Mass, MD, Acting Chief Medical Officer of Marshall Edwards.
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 drug candidate NV-143. The second is a mitochondrial inhibitor program that includes NV-128 and its next-generation candidate NV-344. Both programs are expected to advance into the clinic in 2011. 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.