Novogen Cardiovascular Drug Enters Second Human Clinical Trial
July 06 2004 - 10:04AM
PR Newswire (US)
Novogen Cardiovascular Drug Enters Second Human Clinical Trial
SYDNEY, Australia, July 6 /PRNewswire-FirstCall/ -- Pharmaceutical
company Novogen Limited (NASDAQ:NVGN)(ASX:NRT) is commencing a
second human clinical trial to evaluate its investigational
cardiovascular drug. The new study will be conducted at the Baker
Heart Research Institute in Melbourne using the compound
trans-NV-04. Trans-NV-04 is an advanced version of Novogen's
experimental NV-04 compound. In the current study, trans-NV-04 will
be tested in human subjects who are at risk of cardiovascular
disease, but are otherwise healthy. Initially the trial will
evaluate safety and tolerability in a dose ranging study. This will
be followed by a randomized, cross-over, placebo controlled and
double- blind study in subjects receiving either trans-NV-04 or
placebo. Effects on a number of cardiovascular risk factors,
including arterial stiffness, blood pressure, plasma lipids,
circulating adhesion and inflammatory molecules, insulin
sensitivity and plasma cortisol will be compared between groups. A
trans-NV-04 analogue has been tested in human volunteers in a
pre-phase I study reported previously. In that study the effects of
direct infusion of the drug into the brachial artery induced
elasticity in blood vessels (dilation) and increased forearm blood
flow. In the initial human trial, six out of six subjects responded
favorably following direct infusion of the compound into the blood
stream leading to significant increases in blood flow in a
particular artery. Follow-up laboratory studies have identified
trans-NV-04 as potentially even more effective than the parent
compound but retaining its low side effect and high safety profile.
Previous laboratory studies conducted by the Baker team have
demonstrated that trans-NV-04, in addition to promoting blood
vessel relaxation, acts as an antioxidant and inhibits smooth
muscle cell growth in blood vessels, factors contributing to build
up of obstructive vascular plaques or atherosclerosis. The current
human study will enable a dosing regime to be established which has
the potential to be used in healthy subjects to reduce
cardiovascular risk factors and in people suffering from
atherosclerosis, to reduce the damage in diseased arteries and to
hasten the recovery from surgical interventions used to manage such
disease, such as by-pass surgery and angioplasty. Novogen's
Research Director, Professor Alan Husband, said the trial
represented a significant milestone in the Novogen cardio-vascular
drug program. "We have already demonstrated that our compounds
produce clinically relevant effects in improving cardiovascular
function," Professor Husband said. "This human clinical trial is
intended to demonstrate that improved cardiovascular function can
be realized in patients who are at risk of cardiovascular incidents
and subsequently in patients suffering from life- threatening
cardiovascular disease." Professor Husband said most currently
available drugs used to treat these disorders produced undesirable
side effects. "In contrast trans-NV-04 is expected to be
sufficiently safe to be administered over long periods without side
effects," Professor Husband said. Atherosclerosis,
hypercholesterolaemia and associated vascular disease are prevalent
in the Western world. It is estimated that more than 300 million
individuals in the seven major pharmaceutical markets suffer from
hypercholesterolaemia. An estimated US$17.7 billion is spent
annually on cardiovascular drugs in the United States alone. The
NV-04 research effort has been assisted by an award of A$3.7
million through the Australian government's R&D START program.
Trans-NV-04 is an investigational drug not yet approved for
marketing in the United States. Novogen is advancing clinical
development of its compounds to a point where it can maximize
shareholder value through out-licensing. Novogen has developed a
patented suite of intellectual property around its technology
platform and is coordinating its international research and
clinical development programs in collaboration with some of the
world's leading medical research centers. More information on the
Novogen group of companies and their associated technology
developments can be found at http://www.novogen.com/ and at
http://www.marshalledwardsinc.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: Professor Alan Husband, Research Director
of Novogen Limited, +011 61 (02) 9878 0088; or David Sheon,
+1-202-518-6321, for Novogen Limited Web site:
http://www.novogen.com/ http://www.marshalledwardsinc.com/
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