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 15d-16 UNDER
THE
SECURITIES
EXCHANGE ACT OF 1934
For the
month of April, 2008
Commission
File Number ________________
Novogen
Limited
(Translation
of registrant’s name into English)
140 Wicks
Road, North Ryde, NSW, 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
x Form 40-F o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(l): o
Note:
Regulation S-T Rule 101 (b)( I) only permits the submission in paper of a Form
6-K if submitted solely to provide an attached annual report to security
holders.
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule lO1(b)(7): o
Note:
Regulation S-T Rule l01(b)(7) only permits the submission in paper of a Form 6-K
if submitted to furnish a report or other document that the registrant foreign
private issuer must furnish and make public under the laws of the jurisdiction
in which the registrant is incorporated, domiciled or legally organized (the
registrant’s “home country”), or under the rules of the home country exchange on
which the registrant’s securities are traded, as long as the report or other
document is not a press release, is not required to be and has not been
distributed to the registrant’s security holders, and, if discussing a material
event, has already been the subject of a Form 6-K submission or other Commission
filing on EDGAR.
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 l2g3-2(b) under the Securities Exchange Act of 1934. Yes o No x
If “Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
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)
/s/ Ron
Erratt
Ronald
Lea Erratt
Company
Secretary
Date
2 April, 2008
ASX
& MEDIA RELEASE
2
APRIL, 2008
NOVOGEN
CARDIOVASCULAR DRUG ENTERS PHASE I CLINICAL TRIAL
Sydney,
Australia and New Canaan, Connecticut. Novogen today announced the
commencement of a Phase I human clinical trial of the novel cardiovascular
drug, NV-27. This drug is designed to reduce restenosis or
re-blocking of arteries after surgery to clear blockages, commonly involving
insertion of arterial stents. The study is being conducted in
association with Bond University, Queensland, Australia under the direction of
clinical pharmacologist, Professor Laurie Howes.
“We are
very pleased to be involved in the development of this compound which has the
potential to assist in the management of restenosis in coronary artery stenting”
said Dr Laurie Howes, Professor of Pharmacology and Therapeutics at Griffith and
Bond University Medical School in Queensland, Australia, and the Principal
Investigator of this study.
“We have
extensive experience in the kinetics and safety profile of this class of
compounds and expect that the Phase I goals of safety and tolerability will be
met in this study” said Prof Howes.
Program
Leader of the Novogen Anti-inflammatory and Cardiovascular Drug Research
Program, Dr Cath Walker, said “Restenosis has been termed the ‘Achilles
heel’ of interventional cardiology. There is an unmet therapeutic
need for a simple, safe and durable solution to restenosis. NV-27 is
well placed to address this need.”
The
current study is the first step in the clinical development of the
drug. It will involve initial testing in a small number of healthy
human volunteers to determine the safety and kinetics of NV-27 in
humans. To date it has been demonstrated to be safe in animal studies
and no toxic side effects are expected.
About
NV-27
The drug,
code named NV-27, has been developed from the Novogen flavanoid technology
platform. It is a synthetic analogue based on the phenolic structure
of naturally-occurring isoflavones. The drug has been designed to be
administered orally as an adjunctive therapy to reduce restenosis following
angioplasty (surgical unblocking of arteries) with or without stenting, or
coronary artery bypass surgery.
The
processes causing restenosis are complex, but occur as a direct result of vessel
injury during the stenting procedure, local inflammation and remodelling,
together with the same processes of atherosclerosis that caused the vessel to
block initially. NV-27 has been demonstrated to inhibit those
processes in vitro via
a variety of mechanisms. Importantly,
orally administered NV-27 has been extremely effective in protecting against
restenosis following endothelial injury in animal studies. NV-27
therefore appears to be ideally suited as an orally delivered agent to reduce
restenosis following coronary artery stenting.
About
restenosis
The
coronary arteries supply blood to the heart. Through a variety of
mechanisms including aging, a diet high in fat, smoking and inadequate exercise,
atherosclerosis causes these arteries to block, resulting in angina (heart pain)
or more critically an acute myocardial infarction (heart attack).
These
vessels can be unblocked by a process called angioplasty, where the vessel is
reopened using a balloon inflated inside the artery. More commonly, a
small metal scaffold called a stent can be inserted to hold the artery open for
an extended period. Unfortunately, the vessel often blocks up again
in a process called ‘restenosis’.
Depending
on the type of stent used, the type of lesion and whether or not the patient is
a diabetic and/or a smoker, restenosis may occur in up to 50% of
procedures. The stent then needs to be replaced with
another. If the disease is very severe, a patient may undergo bypass
surgery where the coronary arteries are replaced with veins from other parts of
the body. Again, restenosis can occur, requiring the surgery to be
repeated.
Whilst
the addition of immunosuppressive or anti-proliferative agents such as coating
on stents (so called drug-eluting stents) have reduced the occurrence of
restenosis, it still remains a significant clinical problem, the results of
which can be catastrophic.
About
Novogen Limited:
Novogen
Limited (ASX: NRT NASDAQ: NVGN) is an Australian biotechnology
company that has patented isoflavone technology for the treatment and prevention
of degenerative diseases and disorders. Over the past ten years, Novogen has
conducted the largest and most comprehensive isoflavone clinical testing
programs in the world. Novogen is involved in drug discovery and product
development for disorders that are commonly associated with aging and
coordinates an international clinical research and development program with
external collaborators, hospitals and universities. For more information, visit
www.novogen.com.
Under
U.S. law, a new drug cannot be marketed until it has been investigated in
clinical trials and approved by the FDA as being safe and effective for the
intended use. 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 of our products to obtain such approval,
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