Orphan Drug Status Granted for Marshall Edwards' Investigational Anti-Cancer Drug Triphendiol (NV-196)

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Tue Jan 22, 2008 8:54am EST

  NEW CANAAN, CT, Jan 22 (MARKET WIRE) -- 
 Marshall Edwards, Inc. (NASDAQ: MSHL) announced today that its triphendiol
(previously known as NV-196) has been granted orphan drug status by the U.S.
Food and Drug Administration (FDA) for the treatment of pancreatic cancer and
for the treatment of cholangiocarcinoma, or bile duct cancer.

    An orphan drug refers to a product that is intended for use in a disease
orcondition that affects fewer than 200,000 individuals in the United
States.A grant of orphan drug status provides 7 years of market exclusivity for
the
orphan indication after approval by the FDA, as well as tax incentives, study
design
assistance, and eligibility for grant funding from the FDA during its
development.

    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
healthy
human volunteers with no reported side effects.

    Professor Alan Husband, Group Director of Research for Marshall Edwards,
said,
"This grant of orphan drug status is a significant step in the development
program for triphendiol as a multipotent anti-cancer agent."

    "The activity seen in laboratory testing, coupled with the favorable
safetyprofile observed in early clinical testing, suggest we may finally have
discovered a drug which will be of benefit in these unusually aggressive and
difficult-to-treat diseases," Professor Husband said.

    Pancreatic cancer is considered an "orphan" cancer, because of its
relatively
low incidence and high mortality.  Pancreatic cancer is a malignant tumor
of the pancreas, which is slightly more common in men than in women.  In the
U.S. it is the fourth leading cause of cancer-related death in males and the
fifth
leading cause of cancer-related deaths in women with a death rate estimated
by the National Cancer Institute as 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.

    Bile duct cancer (otherwise known as cholangiocarcinoma) is a malignant
tumor that
develops from the mucus glands lining the bile duct and is also more common in
men than in women.  The American Cancer Society estimated that in 2007
approximately 4,600 people in the United States developed bile duct cancer
outside the liver.  Bile duct cancer is also associated with a poor
prognosis and has limited treatment options(3).

    Triphendiol is a second-generation derivative of phenoxodiol.  Phenoxodiol
is an
investigational drug that is currently undergoing clinical evaluation in a Phase
III
study in platinum resistant ovarian cancer patients, a study that has been
approved under the FDA's Special Protocol Assessment scheme. Patients seeking
more information about the phenoxodiol trial should visit www.OVATUREtrial.com.

    This class of drugs is derived from a proprietary phenolic drug technology
platform
that has produced a number of anti-cancer lead compounds, characterized by
unusually
broad activity against a range of tumor targets in cell based studies, coupled
with data that suggest a highly satisfactory safety profile.

    The CEO of Marshall Edwards, Mr. Christopher Naughton, commenting on the
Company's strategic plan for triphendiol, said, "The Company now intends
tovigorously pursue the clinical development of triphendiol into Phase II
human clinical studies in affected patients during the course of 2008."

    "With phenoxodiol now in a Phase III trial, coupled with this latest boost
in
the development of its second cancer drug, triphendiol, the Company is well
placed to crystallize the value inherent in the technology platform underpinning
these novel drugs," Mr. Naughton said.

    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 the
tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) death
receptors.  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 healthy volunteers.  Compared to phenoxodiol,
triphendiol has substantially greater activity in laboratory testing against
pancreatic cancer and cholangiocarcinoma.

    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
resultingfrom 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.

    


CONTACT:
David Sheon
+1 202 518-6321 (USA)

Prof. Alan Husband
Group Director, Research
Marshall Edwards, Inc.
+61 2 9878 0088 (Australia)

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