6-K: Report of foreign issuer [Rules 13a-16 and 15d-16]

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 March 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 31 March, 2004 By Ronald Lea Erratt Company Secretary

ASX & MEDIA RELEASE
31 MARCH 2004

Investigational anti-cancer drug phenoxodiol produces response
and restores chemo-sensitivity in four studies.

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.

Late-breaking Phase 2 prostate cancer study data included at AACR.
(Orlando, Florida March 31, 2004) Data presented at the 95th
Annual Meeting of the American Association for Cancer Research
(AACR) in Orlando, Florida, confirms that phenoxodiol is on track
in its development as a first-line therapy for early-stage cancers
and as a chemo-sensitizing agent for late-stage cancers.
Phenoxodiol, a XIAP-inhibitor, is an anti-cancer drug being
developed by Marshall Edwards, Inc., (Nasdaq: MSHL).
The data presented concerned clinical studies conducted at U.S.
and Australian hospitals, and pre-clinical studies conducted
at U.S. research institutions.
Interim results of phase 1b/2a data shows dose-related response.
Late breaking data from a Phase 1b/2a clinical trial in late-stage
prostate cancer patients supports the strategy of targeting this
cancer type. Twenty-four patients with malignant prostate cancer
and rising prostate specific antigen (PSA) levels (mean 60
ng/mL at start of study) were treated with phenoxodiol (oral
dosage formulation) 3 times daily, for 3 weeks each month up to
a maximum of 6 months. Patients received 1 of 4 different
dosages; 20, 80, 200 or 400 mg. There were 6 patients per
dose stratum.
This first trial of oral phenoxodiol was designed to confirm
that the dosage form was biologically active. Activity was
determined on the basis of PSA levels in the blood. PSA, a
protein normally secreted by the prostate, is a marker commonly
used to detect the presence of prostate cancer. Although not
an absolute predictor of prostate cancer, it is generally
accepted that as prostate cancer develops, a greater amount
of PSA is released into the blood stream. Objective tumor
response was not an aim of this study.
Interim results indicate that oral phenoxodiol is biologically
active as evidenced by a dose-dependent effect on serum PSA level.
When the 12 patients treated with the 2 highest dosages
(200 and 400 mg) were tested after 3 months of therapy,
2 showed stabilization of their PSA levels,
while 6 (50%) showed a decrease in PSA levels.
Two of these 6 responders showed a decline in PSA levels of
greater than 75%. No toxicity was reported.
The clinical study was conducted in Australia by
Dr. Robert Davies of Sir Charles Gairdner Hospital in Perth,
Professor Alastair Tulloch of St John of God Hospital, Perth,
and Dr. Mark Frydenberg of Monash Medical Centre, Melbourne.
Co-investigator Dr. Davies said, Late-stage prostate cancer
is notoriously unresponsive to anti-cancer therapies, so to
see this degree of response to phenoxodiol confirms our confidence
in this investigational drug.
He also said, While the results of this study suggest that
phenoxodiol may be having a significant anti-cancer effect in
its own right in prostate cancer, we believe that it has the
potential to provide even greater benefit when used in
combination with other drugs.
Dr. Graham Kelly, Executive Chairman of
Marshall Edwards, Inc., said, These data justify moving to
the next step, which is a larger trial to test for objective
tumor response to both phenoxodiol alone and in combination
with chemotherapy, in men with late stage prostate cancer.
Yale University study shows monotherapy response
in advanced ovarian cancer.
The second set of clinical trial data discussed at the
conference concerned the intravenous dosage formulation
of phenoxodiol. This was a Phase 2 study of monotherapy
phenoxodiol in 40 patients with late-stage, unresponsive,
recurrent ovarian cancer.
On average, these patients had undergone 5 different c
hemotherapy regimens, and all patients failed to respond
to salvage therapy. The patients were treated with phenoxodiol
in an attempt to determine whether phenoxodiol had any
anti-tumor effect in such late-stage tumors, and if so,
to identify the appropriate dosage to be used in a follow-up
study where it would be used in combination with standard
chemotoxic drugs.
Intravenous phenoxodiol was administered on 2 consecutive
days per week; patients were randomized to 4 dose levels:
1, 3, 10 and 20 mg/kg. Treatment continued until patients
showed disease progression. Response to therapy was
assessed on the basis of a fall in blood levels of the ovarian
tumor marker (CA125), shrinkage of the tumor mass, or
improved clinical status.
Ten (25%) of the 40 patients had responded when assessed after
6 weeks of treatment, although tumor mass was not assessed
at this time. In 6 of these patients, CA125 levels had fallen
by an average 54%; in the other 4 patients, rapidly rising CA125
levels before the trial commenced had stopped rising
(stabilization) at 6 weeks. At 3 months, 4 of these 10
patients showed stabilized CA125 levels. Almost all of
these responders were in the 2 lowest dosage groups,
confirming laboratory studies that showed a greater anti-tumor
effect for ovarian cancer at lower dosages for phenoxodiol.
Phenoxodiol restores chemo-sensitivity in patients with
advanced ovarian cancer.
Relevant data, however, in terms of the company strategy
of developing phenoxodiol as a chemo-sensitizing agent for
late-stage cancers, came from the follow-up management
of these patients. Following completion of the phenoxodiol
therapy because of disease progression, a number of
the patients were re-challenged with standard
chemotoxic drugs in order to test what effect phenoxodiol
therapy had on their sensitivity to standard
anti-cancer drugs. Because all patients had recurrent disease
despite being heavily treated with chemotherapy, a clinical
response to further chemotherapy was considered unlikely.
In 10 patients who received paclitaxel, 8 of the 10 responded
with an immediate and marked decline (average 64%) in their
CA125 levels; the other 2 women failed to respond and showed
progressive disease. Five of the 10 women treated with
paclitaxel were previously considered either resistant or
refractory to paclitaxel (that is, their disease previously
either had recurred within 6 months of paclitaxel therapy,
or continued to worsen despite paclitaxel therapy).
However, after treatment with phenoxodiol and subsequent
treatment with paclitaxel, 4 of these 5 patients showed
a marked response in their CA125 levels, and 3 remain alive
after an average of 292 days. These patients have yet to be
assessed radiographically to determine the degree of objective
tumor response.
Dr. Thomas Rutherford of the Yale University School of
Medicine, and Principal Investigator in the study, said,
we are excited that phenoxodiol has been able to provide
an effect in women whose disease has been so heavily
pre-treated and for whom we have run out of options.
But we have always believed that the best way to use the
drug was as a chemo-sensitizer, restoring the cancer cells
susceptibility to standard drugs once they have become
resistant to those drugs,
Rutherford added. That is why this preliminary finding
with phenoxodiol and paclitaxel is so exciting. We have
seen women positively respond to paclitaxel after being
pre-treated with phenoxodiol despite their earlier
resistance to paclitaxel.
Dr. Kelly said, This trial represents the first stage
of a two-part program to develop phenoxodiol as a
chemo-sensitizer in ovarian cancer patients.
The trial has been successful in helping us identify
an appropriate, well-tolerated dose of 3 milligrams
per kilogram.
Laboratory data from Yale shows phenoxodiol restores
chemo-sensitivity to a broad range of chemotherapy.
In a pre-clinical study conducted by Yale University
and reported on by Gil Mor M.D., Associate Professor,
Department of Obstetrics and Gynecology, phenoxodiol was
shown to restore sensitivity in ovarian cancer cells not
only to taxane drugs such as Taxotere (docetaxol),
but also to platinum agents such as carboplatin.
Additionally, phenoxodiol in combination with gemcitabine
had a comparable response. Significantly, ovarian
cancer cells resistant to each of these cytotoxic drugs
showed an over 100-fold increase in their sensitivity
to chemotherapy following pre-treatment with phenoxodiol.
Dr. Mor said, What makes the results of this laboratory
study so significant is the confirmation that phenoxodiol
has the capacity to reverse chemo-resistance in
ovarian cancer patients.
Chemo-resistance is one of the greatest problems we
face in cancer therapy. Almost every patient with
advanced ovarian cancer ultimately becomes resistant
to all anti-cancer drugs. We believe that phenoxodiol
is a tool to overcome this problem so we can offer these
patients renewed hope.
NIH laboratory study shows phenoxodiol kills head and
neck cancer cells.
In an additional pre-clinical study conducted by
the NIH and reported on at the conference, the means
by which phenoxodiol was able to stop head and neck
cancer cells (squamous cell carcinomas) from growing,
was described. Of particular relevance, however,
was the fact that phenoxodiol was able to stop the
growth in the laboratory of head and neck cancer cells
and salivary gland cancer cells that were highly
resistant to standard anti-cancer drugs.
Mechanisms of action: phenoxodiol induces apoptosis
by disrupting intra-cellular proteins.
Phenoxodiol has been developed as a highly
selective inducer of apoptosis in tumor cells
that works by removing the intra-cellular proteins
(XIAP, c-FLIP) that play a major role in ensuring
the survival of cancer cells. Removal of these
proteins has the dual effect of rendering the cancer
cell susceptible to the bodys normal defense
mechanisms as well as making it more sensitive to
the cytotoxic effects of standard anti-cancer drugs.
The highly selective nature of phenoxodiol means that
the drug has no discernible adverse effects on
non-tumor cells, and its ability to enhance the
killing effect of other chemotoxics is restricted
to tumor cells.
Marshall Edwards, Inc., is developing phenoxodiol
on two broad therapeutic strategies.
First, as a first-line therapy for early-stage cancer
(including prostate and cervical cancers) where early
detection is possible, and where the cancer is
particularly prone to the apoptotic effect of
phenoxodiol alone. Second, as a first-line therapy
for late-stage cancers (including prostate carcinoma
and renal carcinoma) to improve the responsiveness
to standard chemotoxics in cancers that are
intrinsically poorly sensitive to such drugs, or
as a second-line therapy to restore responsiveness
to standard chemotoxics in cancers
(including ovarian carcinoma) that have acquired
resistance to such drugs.
Phenoxodiol has IND status within the U.S. and has
not yet been evaluated by the FDA for marketing approval.
Phenoxodiol, an investigational anti-cancer drug developed
by pharmaceutical company, Marshall Edwards, Inc.
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,
CEO, Marshall Edwards, Inc., + 61.2.9878 0088