STAMFORD, Conn., Sept. 13 /PRNewswire-FirstCall/ -- A Phase Ib clinical
trial testing the Novogen cardiovascular investigational drug trans NV-04 has
been completed at the Baker Heart Research Institute in Melbourne, Australia.
The trial results show significant improvement in blood pressure and arterial
stiffness in patients at risk of cardiovascular events such as heart attack
and stroke, but with no drug related side effects.
The study tested a metabolite of isoflavones, trans NV-04. This
metabolite, an isoflavonoid compound synthesized by Novogen, was administered
orally to 25 middle-aged men and women who were overweight and also suffered
from at least two complications of fatness: abnormal blood fats, high blood
glucose or raised blood pressure.
The trial was double-blind, so that neither subjects nor investigators
knew the order in which the test isoflavone or a placebo were taken in a
cross-over design in which the drug or placebo was tested over consecutive
periods each of 5 weeks.
Arterial stiffness, measured across the large arteries in the chest and
abdomen by a non-invasive technique, was significantly improved (reduced) by
the course of trans NV-04 treatment. Blood pressures, both systolic and
diastolic, were also lowered significantly.
"The present study confirms that isoflavonoid compounds exert clinically
beneficial effects on the functioning of large arteries," said Professor Paul
Nestel, Principal Investigator in the study and also a Director of Novogen.
"In addition, the test drug was very well absorbed and had an excellent
safety profile."
"It is well known that arteries become stiff as people become older or
overweight, or as their blood pressure rises. With several risk factors for
heart disease, stiffness of arteries is often present and increases the
likelihood of blood pressure rising. The results of this study are
encouraging in producing a range of cardiovascular benefits without side
effects, indicating a potential for this to be used to avoid heart disease in
large numbers of healthy or at risk patients," Prof. Nestel said.
Worsening of arterial stiffness, or compliance, is linked with increased
risk of future heart attacks; therefore it is expected that trials of drugs
that lower arterial stiffness will demonstrate a concomitant lowering of heart
attack risk. Indeed, evidence for improved effects on arterial compliance is
now required by many regulatory bodies for registration of new drugs where
cardiovascular therapeutic claims are sought.
"Previous studies carried out by the Baker Heart Research Institute showed
that arterial stiffness can also be reduced with naturally occurring dietary
isoflavones. This study shows that metabolites formed in the body from
ingested isoflavones are highly active. This explains the success
demonstrated by a number of Novogen's synthetic isoflavonoid compounds in a
range of indication areas," said Professor Alan Husband, Research Director for
Novogen.
Novogen (Nasdaq: NVGN) is an Australian biopharmaceutical company
specializing in the development of therapeutics based on the isoflavonoid
chemical structure. The Company is developing a range of therapeutics across
the fields of oncology, cardiovascular disease and inflammatory diseases and
phenoxodiol, its lead anti-cancer agent is currently in advanced Phase II
clinical trialling. The Novogen group of companies includes the listed
subsidiary Marshall Edwards Inc. (Nasdaq: MSHL; London: MSH).
More information on the Novogen Group can be found at
http://www.novogen.com and http://www.marshalledwardsinc.com.
Under U.S. law, a new drug cannot be marketed until it has been
investigated in clinical trials. After the results of these trials are
submitted in a new drug application to the FDA, the FDA must approve the drug
as safe and effective before marketing can take place.
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.
SOURCE Novogen Limited
 back to top
Related links:
http://www.novogen.com
http://www.marshalledwardsinc.com
CONTACT:
Professor Alan Husband, Research Director of
Novogen Limited (Australia), +011 61 (02) 9878 0088; or David
Sheon of SciWords, LLC, +1-202-518-6321, for Novogen (U.S.)
|
