ASX
& MEDIA RELEASE
25
MARCH, 2008
DATA
TO BE PRESENTED AT AACR REVEALS THAT THE MARSHALL EDWARDS’ COMPOUND TRIPHENDIOL
MAY AID IN TREATMENT OF PANCREATIC CANCER
Novogen
Limited’s subsidiary, Marshall Edwards Inc., (NASDAQ: MSHL), has made the
following announcement:
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 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.
3
Cancer
Facts and Figures, American Cancer Society,
2007.