Data to Be Presented at AACR Reveals That the Marshall Edwards' Compound Triphendiol May Aid in Treatment of Pancreatic Cancer
| Source: Marshall Edwards, Inc.
NEW CANAAN, CT--(Marketwire - March 25, 2008) - 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) for malignant melanoma and for the treatment of
cholangiocarcinoma, bile duct cancer. Triphendiol is being developed by
Marshall Edwards, Inc. (NASDAQ : MSHL ).
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
disease(1). 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 women(2).
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.
About Triphendiol
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 US 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
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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
www.orpha.net/data/patho/Pro/en/MelanomaFamilial-FRenPro3560.pdf).
(2) Cancer Facts and Figures, American Cancer Society, 2007.