ASX
& MEDIA RELEASE
13
NOVEMBER, 2007
RESEARCH
INDICATES SYNTHETIC COMPOUND NV-52 MAY BE USEFUL IN TREATMENT OF INFLAMMATORY
BOWEL DISEASE
Sydney,
Australia and New Canaan, Connecticut. An article published in a
recent edition of the peer review journal
Expert Opinion, Vol. 16, No.
8
, reveals the compound NV-52, developed by Novogen Limited (ASX:
NRT NASDAQ: NVGN), may be useful for the maintenance of remission in
inflammatory bowel disease (IBD).
IBD
comprises two different syndromes: ulcerative colitis, which involves the
rectum
and colon; and Crohn’s disease in which any portion of the gastrointestinal
tract may be affected. The disease is characterised by periods of
remission interspersed with ‘flares’ when the disease relapses, causing acute
abdominal pain, diarrhoea, bleeding and fatigue. There is no cure for
IBD and medical therapy attempts to decrease the frequency of flares -
maintaining remission, or maintenance therapy. Unfortunately, none of
these treatments is without unpleasant side effects.
NV-52,
a
synthetic flavonoid, has completed Phase 1a and 1b clinical trials in healthy
volunteers in Australia, where it demonstrated no detectable side effects,
as
well as the likelihood of requiring just once daily dosing. NV-52 has
been shown to be effective in suppressing colonic inflammation in laboratory
mice and has not displayed any toxicity in
in vitro
and extensive
animal toxicological studies.
NV-52
is
thought to work as a selective thromboxane synthase (TXS) inhibitor, which
researchers believe may play a major therapeutic role in IBD due to its apparent
ability to inhibit pro-inflammatory thromboxanes. Thromboxanes are
produced in excess in inflamed gut mucosa of IBD patients and even in the
uninflamed bowel in Crohn’s disease. The research shows NV-52 may be
effective at preventing and limiting the severity of IBD when administered
in
low doses prior to, and during colonic inflammation.
The
article indicates that NV-52 seems to be a principal developmental drug of
interest at the present time for the prevention of relapse in IBD, particularly
for the large portion of patients who have mild-to-moderate
disease.
“Our
research suggests that NV-52 will be a safe and well-tolerated therapy and
animal studies provide promise that it may have useful efficacy,” said Laurence
Howes, Professor of Pharmacology and Therapeutics at Griffith and Bond
University Medical School in Queensland, Australia, and lead author of the
study. “Improved maintenance therapy remains the greatest unmet
medical need in treating IBD, with the challenge in drug development being
a
non-toxic agent that will maintain disease remission.”
NV-52
is
part of an emerging class of synthetic isoflavonoid
compounds. Isoflavones have been reported to have a wide range of
pharmaceutical effects in animal studies and in clinical research.
Novogen
Limited researchers hope the compound could one day become a leading therapy
for
the treatment and maintenance of remission in IBD.
About
Novogen Limited:
Novogen
Limited (ASX: NRT NASDAQ:
NVGN
) is an Australian biotechnology
company that has patented isoflavone technology for the treatment and prevention
of degenerative diseases and disorders. Over the past ten years, Novogen
has
conducted the largest and most comprehensive isoflavone clinical testing
programs in the world. Novogen is involved in drug discovery and product
development for disorders that are commonly associated with aging and
coordinates an international clinical research and development program with
external collaborators, hospitals and universities. For more
information, visit
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 arty
patents and intellectual property to operate our business; our inability
to
operate our business without infringing the patents and proprietary rights
of
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market
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and
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