Investigational Anti-Inflammatory Drug Produces Promising Results In Animal Studies

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
novogen.



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