June 27, 2011
, Inc. (Nasdaq: MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today the publication of results from pre-clinical studies of Triphendiol, a prodrug of the Company's lead drug candidate NV-143, that demonstrate its anti-proliferative activity in pancreatic cancer as both a monotherapy and as a chemosensitizer. The publication is now available on the
website and scheduled to print in the August issue of the journal.
The studies, conducted in collaboration with lead author
, Ph.D., at the
University of Alabama at Birmingham
Medical Center and the
Yale University School of Medicine
, detail the
activity of Triphendiol in pancreatic cancer cells as well as its
activity in animal models of pancreatic cancer. In addition, both studies show that pre-treatment with Triphendiol enhances the cytotoxic effect of gemcitabine, the standard-of-care chemotherapy currently used to treat advanced pancreatic cancer. An abstract of the publication, entitled "Triphendiol (NV-196), Development of a Novel Therapy for Pancreatic Cancer," can be found at
In previous laboratory studies, Triphendiol demonstrated anti-cancer activity against a broad range of tumor cell lines, including breast, colorectal and ovarian. Once administered, Triphendiol is converted
into an active metabolite called NV-143. In addition to being more active than Triphendiol as a single agent, NV-143 appears to be superior in its ability to synergize with chemotherapy in pre-clinical studies.
has completed the required pre-clinical studies of NV-143 necessary to complete an Investigational New Drug application, which it plans to submit to the U.S. Food and Drug Administration next month.
"These studies add to our growing collection of data regarding the activity of our compounds and their potential ability to enhance the effects of current treatments," said
Robert D. Mass
, MD, Chief Medical Officer of
. "These data further support the clinical development strategy for our lead candidate NV-143, the primary metabolite of Triphendiol, in combination with standard-of-care chemotherapy, while expanding the potential drug combinations we can consider in our randomized Phase II clinical trials."
About Marshall Edwards
, Inc. (Nasdaq: MSHL) is a
-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 Triphendiol and 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
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.