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 April 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 11 May,2004 By /s/Ronald Lea Erratt Company Secretary
ASX MEDIA RELEASE
12 MAY 2004
NOVOGEN'S SECOND ANTI-CANCER DRUG ENTERS HUMAN CLINICAL TRIALS
(Sydney Australia) - Novogen has commenced a human clinical trial
of a new patented anti-cancer compound, NV-18.
NV-18 is derived from phenoxodiol, the Company's first
anti-cancer drug that is now producing data in human
clinical trials for the treatment of late-stage ovarian
and prostate carcinomas.
NV-18 has been approved for a Phase Ia study at St George
Hospital in Sydney, Australia.
The study will determine the drug's bio-availability,
pharmacokinetic profile, and acute safety.
The drug will be administered in three different ways:
- - orally;
- - by bolus intravenous injection; and
- - by slow intravenous infusion over four hours.
All of these modes of delivery will be administered to
6 patients with solid tumours and will be conducted over a
trial period of 8 weeks.
NV-18 is a product of the Novogen diphenolic synthetic
analogue program that is creating drugs with diverse
activities against specific types of cancer.
Like phenoxodiol, NV-18 is broadly effective in the
laboratory against almost all human cancer types, but
NV-18 is distinctive in showing particular potency
against melanoma and cholangiocarcinoma (cancer of the
gall-bladder).
In laboratory studies conducted in collaboration with
researchers at the University of Newcastle (Australia)
and the University of Alabama at Birmingham (USA), NV-18
has proven highly effective at killing both melanoma cells
and cholangiocarcinoma cells, cancers that are typically
highly resistant to standard anti-cancer drugs.
Novogen proposes to evaluate the ability of NV-18 to act as
an effective monotherapy against these two cancer types.
However, it is anticipated that its primary role will be
to act as a chemo-sensitiser for standard anti-cancer agents.
Novogen scientists, in pre-clinical studies, have shown that
NV-18 is particularly effective as a chemo-sensitising agent,
rendering chemo-resistant melanoma cells highly susceptible
to the killing effect of standard anti-cancer drugs such
as taxanes.
Chemo-sensitisation is a new direction for anti-cancer
therapy.
Various cancers, such as cancers of the prostate, kidney
and cervix, are relatively insensitive to chemo-toxic drugs
from the start, while others, such as cancers of the ovary
and breast, eventually become insensitive after showing
initial responsiveness.
A number of mechanisms within the cancer cell
lead to such inherent or acquired resistance, and it now
is recognised that overcoming these mechanisms is a
logical and achievable objective in the treatment of cancer.
In preclinical studies, NV-18, like phenoxodiol, is able
to overcome and reverse those resistance mechanisms,
rendering cancer cells susceptible to standard anti-cancer
drugs including those based on the taxane and platinum
structures that are highly effective at killing cancer cells.
The planned clinical development program for NV-18 will focus
firstly on malignant melanoma, a cancer that is
characterised by being poorly responsive to standard
anti-cancer drugs and having a poor prognosis once it has
metastasised.
Novogen has entered into a licence option with a Marshall
Edwards Inc (Nasdaq: MSHL) company.
This option grants to Marshall Edwards the first right to
accept and the last right to match any proposed dealing by
Novogen with its intellectual property rights relating to
certain synthetic pharmaceutical compounds, including this
compound, NV-18. Marshall Edwards Inc is currently 87 per
cent owned by Novogen Limited.
Currently Novogen has biological response modifying compounds
undergoing development in the areas of cancer, cardio-vascular,
skin repair, anti-inflammatory and wound healing.
The lead anti-cancer drug, phenoxodiol, which is licensed to
Marshall Edwards, is being clinically trialled as a stand-alone
therapy and as a chemo-sensitising agent to strengthen or
reactivate existing cancer treatments.
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 a
round 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