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<SEC-DOCUMENT>0001075880-05-000009.txt : 20050126
<SEC-HEADER>0001075880-05-000009.hdr.sgml : 20050126
<ACCEPTANCE-DATETIME>20050126074511
ACCESSION NUMBER:		0001075880-05-000009
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20050126
FILED AS OF DATE:		20050126
DATE AS OF CHANGE:		20050126

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:		05548389

	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>asxannounc050126.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 January, 2005

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 26 January, 2005  By /s/Ronald Lea Erratt Company Secretary

ASX & MEDIA RELEASE
26 JANUARY, 2005

FDA GRANTS FAST TRACK DESIGNATION FOR PHENOXODIOL IN ORAL DOSAGE FORM
FOR PROSTATE 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 - January 26, 2005) 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 hormone-refractory prostate cancer (HRPC).

The successful application for fast track status was based on data
derived in a Phase Ib/IIa study, conducted in two Australian
hospitals, in which men with late stage HRPC were treated with
the oral dosage form of phenoxodiol as a monotherapy.

The preliminary outcome of this study was presented to the
American Association of Cancer Research (AACR) conference on
Basic, Translational and Clinical Advances in Prostate Cancer
in November 2004 (for the press release and study findings,
see http://tinyurl.com/5zeck).  In the study, dosages of
phenoxodiol ranging from 200mg to 400mg 8-hourly had a significant
effect on disease progression, as evidenced by falls in PSA levels,
and suppression of those levels for a period of at least 6 months.
Most of the patients remain on phenoxodiol therapy for
periods up to 18 months without evidence of disease progression.

Of particular relevance to the FDA is that prostatic adenocarcinoma
that is refractory to both hormonal therapy and cytotoxic
chemotherapy is associated with severe morbidity and a life
expectancy of less than 1 year, and as such meets the criteria
for a serious and life-threatening disease.

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

"This decision of the FDA underpins our confidence in phenoxodiol
being an effective therapy for late-stage prostate cancer.
The next step is to take phenoxodiol into a pivotal study
where we will test its ability to halt disease progression in
men with prostate cancer who have failed the standard treatment
Of hormone therapy and docetaxel chemotherapy," said
Dr. Graham Kelly, Executive Chairman of Marshall Edwards, Inc.

Mr. Christopher Naughton, CEO of Marshall Edwards, Inc., said,
"This decision represents a significant endorsement of the
potential of phenoxodiol, coming just 2 months after the FDA
granted fast track status for phenoxodiol for late-stage
ovarian cancer.  The Company now has two opportunities to pursue
for the continuing development of phenoxodiol for the benefit of
both prostate cancer and ovarian cancer patients."
Phenoxodiol in intravenous form was granted fast track status
by the FDA in November 2004 for its intended use in patients
with recurrent ovarian cancer.

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)
- - that 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

Phenoxodiol works selectively on tumor cells, thought to be due
to its interaction with the enzyme, 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 Prostate Cancer
Prostate cancer is one of the most common types of cancer
among men in Western countries.  The American Cancer Society
estimates there will be 232,000 new cases of prostate cancer
in the United States in 2005 and that about 30,350 men will
die of this disease.  Prostate cancer is strongly associated
with the male sex hormone, testosterone, and most early cases
of prostate cancer respond for some time to hormonal therapy
that blocks the ability of testosterone to stimulate the cancer.
However, the majority of cases of prostate cancer eventually
become independent of testosterone, at which time they are
known as hormone-refractory prostate cancer (HRPC).
The cancer at this stage typically is metastatic, with
a patient survival time typically in the range of 1 to 2 years.

The FDA recently approved the combination of docetaxel
(Taxotere) and prednisone for the treatment of HRPC.
That combination produced an overall increase in survival
of 10 weeks (from an average of 16.4 months to an average
of 18.9 months).

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 diphenolic 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.



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

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