ASX
& MEDIA RELEASE
22
JANUARY, 2008
ORPHAN
DRUG STATUS GRANTED FOR MARSHALL EDWARDS’ INVESTIGATIONAL ANTI-CANCER DRUG
TRIPHENDIOL (NV-196)
Novogen
Limited’s subsidiary, Marshall Edwards Inc., (NASDAQ: MSHL), has made the
following announcement:
Sydney,
Australia and New Canaan, CT, 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 US 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 tumours has demonstrated the
activity of triphendiol against cancer cells. In mice bearing a human
pancreatic cancer tumour, triphendiol administration resulted in a mean
reduction in tumour 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 multi-potent anti-cancer agent.”
“The
activity seen in laboratory testing, coupled with the favourable 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 tumour of the
pancreas, which is slightly more common in men than in women. In the
US 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 US 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 tumour 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, characterised by
unusually broad activity against a range of tumour 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 crystallise 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 chemosensitising
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 tumour necrosis
factor-related apoptosis-inducing ligand (TRAIL) death receptors. It
exhibits high selectivity, little effect on non-tumour 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
characterised 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 specialising 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
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.