Data to be Presented at AACR Reveals that Triphendiol May Aid in the Treatment of Pancreatic Cancer
Mar 25, 2008
New Canaan, CT, March 25, 2008 - Marshall Edwards, Inc., (Nasdaq: MSHL). The abstract for a late breaking presentation at the Annual Meeting of the American Association for Cancer Research, April 12-16, San Diego, Calif., is now available at www.aacr.org (abstract# 8989). The abstract is titled Triphendiol (NV-196) induces apoptosis and sensitizes pancreatic cancer cells to gemcitabine. Triphendiol was recently granted orphan drug status by the U.S. Food and Drug Administration (FDA).
There is an urgent need for new pancreatic cancer treatments because fewer than 20 percent of patients are candidates for surgery (pancreotectomy). Current treatment is limited to chemotherapy with gemcitabine, to which most patients are resistant or acquire resistance. This study assessed the potential of triphendiol as a treatment for pancreatic adenocarcinoma using three representative cell lines. Triphendiol induced apoptosis (cell death) in all cell lines and pre-treatment with triphendiol increased gemcitabine-dependent apoptosis. Animal model studies showed that triphendiol in combination with gemcitabine inhibits tumor growth more effectively than each drug alone. Both triphendiol and gemcitabine induce apoptosis via a mitochondrial pathway.
Laboratory testing in vitro and in animals bearing human pancreatic and bile duct tumors has demonstrated the activity of triphendiol against cancer cells. In mice bearing a human pancreatic cancer tumor, triphendiol administration resulted in a mean reduction in tumor volume by 62 percent compared with untreated control animals. In the two Phase I clinical studies completed thus far, the investigational drug has demonstrated acceptable pharmacokinetic profiles in human volunteers with no reported side effects.
Professor Alan Husband, Group Director of Research for Marshall Edwards, says, "This study being presented at AACR is an important step in the clinical development program for triphendiol as a safer multipotent anti-cancer agent.
"We continue to see evidence that triphendiol will be of benefit in unusually aggressive and difficult-to-treat diseases such as pancreatic cancer," Professor Husband said.
Pancreatic cancer is considered an "orphan" cancer, because of its relatively low incidence and high mortality. It is slightly more common in men than in women. In the U.S., it is the fourth leading cause of cancer-related death in men and the fifth leading cause of cancer-related deaths in women with a death rate estimated by the National Cancer Institute of approximately 96 percent of patients with the disease1. The American Cancer Society estimated the number of new cases of pancreatic cancer in the U.S. in 2007 as 37,170, with 18,830 cases diagnosed in men and 18,340 in women2.
Pancreatic cancer has a poor prognosis. The disease is difficult to diagnose in its early stage, and patients usually present with incurable disease. It has a high mortality rate, and no therapy has been shown to significantly impact survival.
Triphendiol (NV-196) is another investigational drug in the Marshall Edwards, Inc., oncology drug pipeline, currently being developed as an orally-delivered chemosensitizing agent, intended for use in conjunction with standard chemotoxic anti-cancer drugs for the treatment of late stage pancreatic cancer, cholangiocarcinoma, and melanoma. Triphendiol is broadly cytostatic and cytotoxic against most forms of human cancer cells in vitro, and has been shown to cause cell cycle arrest (or stop cells increasing in number) and to induce apoptosis (or initiate programmed cell death) in various cancer cell lines.
Biological studies suggest a mechanism of cytotoxicity that involves mitochondrial depolarization and downregulation of XIAP. It exhibits high selectivity, little effect on non-tumor cells and no observable toxicity in animals at therapeutically effective doses. In human studies conducted so far, no adverse events or side effects have been reported when administered to volunteers.
About Marshall Edwards, Inc. and Novogen Limited.
Marshall Edwards, Inc., is a specialist oncology company focused on the clinical development of novel anti-cancer therapeutics. These derive from a flavonoid technology platform that has generated a number of novel compounds characterized by broad ranging activity in laboratory testing against a range of cancer targets with few side effects. The ability of these compounds to target an enzyme present on the surface of cancer cells, and inhibit the production of pro-survival proteins within the cancer cell suggests that they may possess a unique combination of efficacy and safety. Marshall Edwards, Inc. has licensed rights from Novogen Limited (ASX: NRT; NASDAQ: NVGN) to bring three oncology drugs - phenoxodiol, triphendiol (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 www.marshalledwardsinc.com and 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.
1 National Cancer Institute, A Snapshot of Pancreatic Cancer (available at http://planning.cancer.gov/disease/snapshots.shtml) .
2 Cancer Facts and Figures, American Cancer Society, 2007.
3 Cancer Facts and Figures, American Cancer Society, 2007.