6-K: Report of foreign issuer [Rules 13a-16 and 15d-16]
Published on
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington. D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR I5d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of July 2004
Novogen Limited
(Translation of registrant's name into English)
140 Wicks Road, North Ryde, NSW, 2113, Australia
(Address of principal executive office)
[Indicate by check mark whether the registrant files or will file
annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F v Form 40-F
[Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934. Yes No
[If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2 (b):
82- ________________ .1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
Novogen Limited
(Registrant)
Date 6 July,2004 By /s/Ronald Lea Erratt Company Secretary
ASX MEDIA RELEASE
6 JULY 2004
NOVOGEN CARDIOVASCULAR DRUG ENTERS SECOND HUMAN
CLINICAL TRIAL
Pharmaceutical company Novogen Limited is commencing
a second human clinical trial to evaluate its 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 randomised,
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
favourably 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 realised 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.
Novogen is advancing clinical development of its
compounds to a point where it can maximise shareholder
value through out-licensing.
Novogen has developed a patented suite of intellectual
property around its technology platform and is
co-ordinating its international research and clinical
development programs in collaboration with some of
the world's leading medical research centres.
More information on the Novogen group of companies
and their associated technology developments can be
found at www.novogen.com and at 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 managements 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.
CONTACT: US-Australia: Mr Christopher Naughton,
CEO, Marshall Edwards, Inc., + 61.2.9878 0088