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 February 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 9 January, 2004 By Ronald Lea Erratt Company Secretary
ASX & MEDIA RELEASE
9 FEBRUARY 2004
STUDY AT YALE UNIVERSITY SUPPORTS DEVELOPMENT OF PHENOXODIOL
AS A DRUG TO RESTORE CHEMO-SENSITIVITY IN NON-RESPONSIVE WOMEN
WITH RECURRENT OVARIAN CANCER
Novogen Limiteds subsidiary, Marshall Edwards, Inc.
(LSE AIM: MSH and Nasdaq: MSHL) has just made the following
announcement to the London Stock Exchanges Alternative Investment
Market.
(San Diego, Calif. February 9, 2004) Researchers from Yale
University School of Medicine reported preliminary results of
a dose finding study in women with recurrent ovarian cancer
using phenoxodiol, an investigational anti-cancer drug being
developed by Marshall Edwards, Inc. (Nasdaq: MSHL; LSE AIM: MSH).
This early clinical testing supports the ability of phenoxodiol
to act as both an anti cancer agent in its own right and a
chemo sensitizing agent that restores responsiveness of
ovarian cancer cells to standard chemotherapies.
Phenoxodiol is an investigational drug and has not yet been
approved for marketing in the U.S. The data were presented
yesterday at the 35th Annual Meeting of the Society of Gynecologic
Oncologists.
Phenoxodiol as Monotherapy
The data reflect outcomes from the first 20 of 40 measurable
subjects at the first two doses tested in a dosing study
o evaluate the effect of certain doses of phenoxodiol on
disease progression and tumor response in women with recurrent
disease that has become unresponsive to standard chemotherapy.
According to the Yale researchers, of the 20 subjects who s
tarted the drug course, 13 were able to finish a three-month
cycle, and five of the 20 subjects (25 percent) were
considered to have had disease stabilization.
All patients ultimately showed disease progression.
However, no toxicity was attributed to phenoxodiol at the
two dosing levels reported at this time. Complete data from
this study is not yet available according to the Yale
researchers, and will be presented at a later date.
While pre clinical studies of phenoxodiol have shown
the ability to stop ovarian cancer growth in animals
in its own right, the Yale researchers and the drugs
developer, Marshall Edwards, Inc., are developing the drug
in late stage ovarian cancer as a chemo sensitizer,
restoring the sensitivity of the cancer cells to the
cytotoxic action of standard chemotherapeutic drugs,
in the expectation that that form of usage would deliver
a greater anti tumor effect in such advanced cases of cancer.
Patients received phenoxodiol twice a week, which
is how we believe it will be used in combinational
therapy, said principal investigator Thomas Rutherford,
M.D., Associate Professor of Gynecology and Reproductive
Sciences. We did not expect to see a major
anti tumor effect when used at this dose,
so it is encouraging to see an apparent 25 percent
stability rate in such unresponsive cancers. These
results give us confidence in the potential use of
phenoxodiol for the treatment of ovarian cancer. We are
highly encouraged by this outcome.
Phenoxodiol with Subsequent Chemotherapy
In an interim analysis of the entire study of 40 patients,
where the Yale researchers focused on paclitaxel
challenged patients, the researchers observed that eight
of nine patients who were treated with paclitaxel following
completion of the phenoxodiol trial showed marked,
declining levels of CA125, a tumor marker for ovarian cancer.
Four of these patients had previously been defined as
paclitaxel resistant.
This is a preliminary finding only, but one that
we find highly encouraging because it supports in humans
what we saw in the laboratory that phenoxodiol is a
powerful chemo sensitizer, said Gil Mor MD, PhD,
Associate Professor and a co-investigator in the study.
Our experience is that few patients respond to follow-up
therapy with taxanes once they have developed
chemo resistance, so to see this result is very encouraging.
Pre clinical studies in cells and in animals showed
that phenoxodiol was able to induce in chemo resistant
ovarian cancer cells susceptibility to being killed
by extremely low doses of standard drugs such as
cisplatin and paclitaxel.
Dr. Graham Kelly, Executive Chairman of Marshall Edwards,
Inc., said, We will be commencing a formal combinational
study in ovarian cancer patients within the next couple
of months. That will be the first time that we will
have had the opportunity to use the drug the way that
we believe it should be used. The current study has been
useful in demonstrating the benefit of low doses of
phenoxodiol, and we will be using the same low dose
that has shown such promise in the current study.
According to the Ovarian Cancer National Alliance,
ovarian cancer is the deadliest of the gynecologic
cancers, and is the fifth leading cause of cancer death
among U.S. women. Currently, 50 percent of the women diagnosed
with ovarian cancer die from it within five years,
largely because the cancer ultimately develops resistance
to standard anti cancer therapies.
Marshall Edwards, Inc., is developing phenoxodiol
both as a monotherapy for the treatment of early stage
cancers (e.g. cervical, vaginal and prostatic adenocarcinomas)
and as a chemo sensitizer in combinational therapy for
late stage cancers (e.g. ovarian, prostate, renal,
pancreatic carcinomas).
Marshall Edwards, Inc., manages its international
research and development programs using the expertise
and clinical research capabilities of universities and
hospitals in the U.S., Australia and Europe.
Marshall Edwards, Inc., has licensed rights to bring
phenoxodiol to market globally from its parent company,
Novogen Limited. (Nasdaq: NVGN). Novogen is developing
a range of therapeutics across the fields of oncology,
cardiovascular disease and inflammatory diseases based on
its phenolic drug technology platform.
More information on phenoxodiol and on the Novogen group of
companies can be found at www.marshalledwardsinc.com and
www.novogen.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,
President and CEO of Marshall Edwards, Inc., + 61.2.9878 0088