Data to Be Presented at AACR Reveals That the Marshall Edwards' Compound Triphendiol May Aid in Treatment of Pancreatic Cancer
March 25 2008 - 8:02AM
Marketwired
NEW CANAAN, CT . 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 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
www.orpha.net/data/patho/Pro/en/MelanomaFamilial-FRenPro3560.pdf).
(2) Cancer Facts and Figures, American Cancer Society, 2007.
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