NEW CANAAN, CT--(Marketwire - January 22, 2008) - 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 or
condition 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 safety
profile 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 to
vigorously 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 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.
Contact Information: CONTACT:
David Sheon
+1 202 518-6321 (USA)
Prof. Alan Husband
Group Director, Research
Marshall Edwards, Inc.
+61 2 9878 0088 (Australia)