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<SEC-DOCUMENT>0001075880-04-000039.txt : 20041104
<SEC-HEADER>0001075880-04-000039.hdr.sgml : 20041104
<ACCEPTANCE-DATETIME>20041104081501
ACCESSION NUMBER:		0001075880-04-000039
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20041104
FILED AS OF DATE:		20041104
DATE AS OF CHANGE:		20041104

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NOVOGEN LTD
		CENTRAL INDEX KEY:			0001075880
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			0630

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-29962
		FILM NUMBER:		041118003

	BUSINESS ADDRESS:	
		STREET 1:		140 WICKS RD
		STREET 2:		NORTH RYDE
		CITY:			NEW SOUTH WALES 2113
		STATE:			C3
		ZIP:			2113
		BUSINESS PHONE:		01161298780088

	MAIL ADDRESS:	
		STREET 1:		107 NORTH RYDE
		CITY:			SYDNEY
		STATE:			C3
		ZIP:			1670
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>asxannounc0411041.txt
<TEXT>
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 November 2004

Novogen Limited
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 4 November,2004  By /s/Ronald Lea Erratt Company Secretary

ASX & MEDIA RELEASE
4 NOVEMBER 2004

US FDA GRANTS MARSHALL EDWARDS INC FAST TRACK DESIGNATION FOR
PHENOXODIOL FOR RECURRENT OVARIAN CANCER
Novogen Limited's subsidiary, Marshall Edwards, Inc.
(LSE AIM: MSH and Nasdaq: MSHL) has just made the following
announcement to the London Stock Exchange's Alternative
Investment Market.

(Washington, DC - November 3, 2004)  Marshall Edwards, Inc.,
(Nasdaq: MSHL/LSE AIM:MSH) today announced that the
U.S. Food and Drug Administration (FDA) has granted the
investigational anti-cancer drug, phenoxodiol, Fast Track status
for its intended use in patients with recurrent ovarian cancer.

In approving phenoxodiol for fast track status, the letter
from FDA stated:

"We are granting fast track designation for the following reasons:
1.	Recurrent ovarian cancer that is resistant
or refractory to platins and taxanes is a life-threatening condition
2.	Phenoxodiol intravenous demonstrates potential to
address an unmet medical need by restoring chemo-sensitivity
in resistant/refractory ovarian cancer."

The Fast Track application submitted to the FDA contained
clinical data including tumor measurements based on radiographic
examination.  The data are from the current Phase Ib/IIa study
where patients with recurrent ovarian and primary peritoneal
cancers are receiving phenoxodiol (intravenous dosage form)
in combination with paclitaxel in those patients where the
cancer is refractory or resistant to taxanes, or in combination
with cisplatin where the cancer is refractory or resistant to
platinum-based drugs.

Under the FDA Modernization Act of 1997, designation as a
Fast Track product means that the drug for the designated
indication is eligible for accelerated marketing approval
programs.  More information on the FDA Fast Track program
is available at http://www.fda.gov/cber/inside/fastrk.htm

"We are developing phenoxodiol for the treatment of a wide
range of cancers, but for the purpose of this Fast Track Program,
we are focusing on its use as a chemo-sensitizing agent
in recurrent, late-stage ovarian cancer",
said Dr. Graham Kelly, Executive Chairman of Marshall Edwards, Inc.

"Ovarian cancer is one of the most devastating forms
of cancer, with half of the women diagnosed with it
dying within five years," Dr. Kelly said.  "The FDA's
decision to accept phenoxodiol into its Fast Track Program
reflects the dire need to provide help for women with this
deadly disease once they become resistant to standard
anti-cancer drugs."

Mr. Christopher Naughton, CEO of Marshall Edwards, Inc.,
said, "Our goal is to continue the development of phenoxodiol
as rapidly as possible for the benefit of ovarian cancer
patients.  We look forward to working closely with the FDA
as we continue the development of phenoxodiol for this and
all other indications under development."

About phenoxodiol
Phenoxodiol is an investigational product that regulates
signal transduction pathways in cancer cells resulting in
the break down of  the intra-cellular proteins
- - XIAP (X-linked Inhibitor of Apoptosis Protein) and
FLIP (Fas Ligand Inhibitory Protein) - which block the
ability of the cancer cell to undergo apoptosis via the
death receptor mechanism.1  While these proteins play a
vital role in preventing unintentional cell death in
healthy cells, they are over-expressed in many forms of
cancer, as well as being associated with the development
of resistance to anti-cancer drugs.2

Pre-clinical studies have shown that by targeting these
anti-apoptotic proteins, phenoxodiol is able to promote
death of ovarian cancer cells that are highly resistant
to standard anti-cancer drugs, as well as being able to
restore sensitivity in these cells to standard anti-cancer
drugs such as taxanes. 3

Phenoxodiol works selectively on tumor cells because of
its interaction with the tumor-specific NADH oxidase,
which is restricted to cancer cells.  Clinical trials to
date have revealed no significant drug related adverse
side effects.
Phenoxodiol is an investigational drug and, as such, is
not approved for marketing in the United States.

About Ovarian Cancer
Ovarian cancer is the most lethal gynecological
malignancy, and the fourth leading cause of cancer
related death in women in the United States.
The American Cancer Society reports that an estimated
25,580 new cases of ovarian cancer will be diagnosed
each year in the United States and 16,090  deaths will
occur.  The lifetime probability of woman developing
ovarian cancer is 1 in 59.  The high mortality is due
mainly to the inability to detect early disease, with
approximately 80 percent of patients being diagnosed
in advanced-staged disease.  However, even in those
patients diagnosed with Stage I or Stage II disease,
the five-year survival rate ranges from 60 to 90 percent
depending on the degree of tumor differentiation.
Despite treatment advances over the past decade, there
has been no advance in overall survival.  The reason for
this is the high rate of relapse.
Of patients who respond to first-line chemotherapy,
less than 10 to 15 percent of these will remain in
remission, and most relapsed cases are chemo-resistant.

The failure of some ovarian cancers to respond to
first-line chemotherapy and the development of resistance
to multi-drug therapies represent the major hurdles
to effective therapy of ovarian cancer.

About the current study
The current Phase Ib/IIa study is an open label,
randomized study being conducted at two sites
(Yale-New Haven Hospital, New Haven, CT, USA, and
Royal Women's Hospital, Melbourne, VIC, Australia)
and involving women with recurrent ovarian cancer
that is either resistant or refractory to
taxane-and/or platinum-based drugs.
The definition of 'resistant' is disease progression
within six months of commencement of drug therapy,
and 'refractory' is disease progression while
undergoing drug therapy.

Patients are being randomized to one of three treatment
groups - (i) phenoxodiol + cisplatin,
(ii) phenoxodiol + paclitaxel, and (iii) paclitaxel only,
converting to phenoxodiol + paclitaxel after
disease progression has been demonstrated.
Phenoxodiol is administered by intravenous infusion
on two consecutive days per week and the second drug
administered intravenously immediately following the
second phenoxodiol administration.  Treatment is weekly
on a continuous basis until either disease progression
or complete response as determined by the absence of
detectable disease. There are 20 subjects per
treatment group.  Phenoxodiol is being administered
at a dosage of 3 mg/kg; the dosages of paclitaxel and
cisplatin are standard but adjustable to ensure that
toxicity is no greater than Grade 1,4 being the least
toxic grade.

About Novogen Limited and Marshall Edwards, Inc.
Phenoxodiol has been developed by Novogen Limited,
an Australian biopharmaceutical company that is
specializing in the development of therapeutics
based on the isoflavonoid ring structure.  Novogen,
based in Sydney, Australia, is developing a range of
therapeutics across the fields of oncology,
cardiovascular disease and inflammatory diseases.

Marshall Edwards, Inc. has licensed from Novogen
Limited. the rights to bring phenoxodiol to the global
market
More information on phenoxodiol and on the Novogen
group of companies can be found at
www.marshalledwardsinc.com and 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 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

</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
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