Investigational Anti-Inflammatory Drug Produces Promising Results in Animal Studies
July 30 2007 - 10:03AM
PR Newswire (US)
STAMFORD, Conn. and SYDNEY, Australia, July 30
/PRNewswire-FirstCall/ -- 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. DATASOURCE:
Novogen Limited CONTACT: Prof. Alan Husband, Group Director of
Research, Novogen Limited, +61-2-9878-0088 Web site:
http://www.novogen.com/
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