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Investigational Anti-Inflammatory Drug Produces Promising Results In Animal Studies
Aug. 01, 2007
As edited by Joint-Pain-Forum.com
A new investigational anti-inflammatory drug has produced
promising results in scientific animal studies as an arthritis control
therapy.
The new drug is a proprietary compound developed by
Australian biotechnology company Novogen Limited (Nasdaq: NVGN; ASX:
NRT) from its phenolic technology platform.
The effect of the
new drug was examined using a well established model of arthritis in
rats which mimics the joint inflammation found in human arthritis. A
joint 'score' was determined based on the degree of swelling and
redness, as well as the number of joints involved. In the Novogen
study, the scoring was performed by an operator 'blinded' to the
identity of the treatment the rats received. A group of eight rats
given the drug in their feed showed significantly lower joint scores (p
= 0.008) when compared with the joint scores from another group of
eight rats given untreated feed.
The research, made public
today, was conducted by Associate Professor Michael James, the Chief
Hospital Scientist at the Rheumatology Unit in the Royal Adelaide
Hospital. The study was conducted with the approval of the Royal
Adelaide Hospital Animal Ethics Committee according to National Health
and Medical Research Council guidelines.
The drug is one of a
family of novel anti-inflammatory therapeutics discovered by Novogen,
known as FAIMs (flavonoid anti-inflammatory molecules).
Professor James said that the FAIM concept involved a new approach to treating arthritis, and other inflammatory conditions.
"These results are encouraging and suggest that the FAIM concept is
valid and could lead to a new class of anti-inflammatory drugs that
would not be expected to have the safety problems of the existing
anti-inflammatory agents," Professor James said.
FAIMs comprise
a family of therapeutics presenting a new method of treating
inflammation. These compounds possess robust anti-inflammatory activity
in vitro and, as now demonstrated also in vivo, and are designed to
avoid cardiovascular, gastrointestinal and renal side effects and may
even be cardio-protective.
Inflammation and pain are currently
most commonly treated with non- steroidal anti-inflammatory drugs, or
NSAIDs. However, these are associated with undesirable side effects,
including gastrointestinal bleeding and ulcers, as well as kidney
damage.
Recently, it has also been highlighted that these
agents, particularly the selective COX-2 inhibitors, are associated
with an increase in heart attacks and other adverse cardiovascular
events. These problems occur because NSAIDs all work by inhibiting the
enzyme called COX.
Program Leader of the Novogen
ant-inflammatory and cardiovascular drug research program, Dr. Cath
Walker, said the mechanism of action for the anti- inflammatory effect
of those FAIMs was now established within the Novogen research program
and had been accomplished by mechanisms other than COX inhibition.
"This means they should not have the side effects of NSAIDS or selective COX-2 inhibitors," Dr. Walker said.
"This result provides encouragement that the FAIM concept should be pursued in human clinical studies.
"Our intention is to determine whether they will be effective in
treatment of arthritis, back pain and other inflammatory conditions,"
Dr. Walker said.
About Novogen
Novogen is an Australian based biotechnology company in the business of
research and development of drugs derived from its phenolic technology
platform. The Company manages its research and development programs
utilizing the expertise and clinical research capabilities of
universities and hospitals in Australia, USA and Europe. Novogen's drug
program is researching and developing compounds for the treatment of
cancer, cardiovascular disease, inflammatory bowel disease and
osteoarthritis. To date Novogen has had 73 patents granted and a
further 225 patents are pending.
Novogen is the world leader in isoflavone research. From its original
technology platform of natural isoflavones (represented in OTC products
such as Promensil) the Company has developed a discovery program
surrounding novel chemical entities based on a flavonoid scaffold. One
of these compounds, phenoxodiol, is currently in Phase III clinical
trialing for treatment of late stage ovarian cancer.
Further information on the Novogen Group can be found at http://www.novogen.com.
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.
Novogen Limited
http://www.novogen.com
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