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 21 April, 2004 By Ronald Lea Erratt Company Secretary
ASX & MEDIA RELEASE
21 APRIL, 2004
NEW TRIAL TO EVALUATE PHENOXODIOL AS CHEMO-SENSITIZING
AGENT IN PATIENTS WITH CHEMO-RESISTENT 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, 21 APRIL, 2004 Marshall Edwards, Inc.,
(NASDAQ: MSHL) has commenced a multi-center, multi-national
clinical trial that will study the ability of the
investigational anti-cancer drug, phenoxodiol, to restore
the sensitivity of ovarian cancer to the standard chemotherapies,
paclitaxel and cisplatin. The first site to enroll patients
for this study is Yale-New Haven Hospital, New Haven,
Connecticut, USA. The second enrollment site will be announced
in June 2004.
Laboratory studies have shown that phenoxodiol has the
ability to restore sensitivity to standard chemotherapies
in ovarian cancer cells that have been obtained from women
whose tumors had previously become resistant to those drugs.
Subsequent to a just-completed Phase I/II study, the
prelude to this study, some women with recurrent ovarian
cancers that were either resistant or refractory to
standard chemotherapies such as paclitaxel, showed
encouraging evidence of restoration of sensitivity to
paclitaxel following phenoxodiol therapy, despite the
fact that the two drugs were not used in the manner
considered to be ideal in order to achieve reversal of
chemo-resistance.
The new study will enroll at Yale 40 patients with
recurrent, late-stage ovarian and primary peritoneal
cancers that have become refractory to taxane-based
(paclitaxel, docetaxol, taxotere) and/or platinum-based
(cisplatin, carboplatin) drugs. Refractory cancers are
those that acquire resistance to a particular drug to the
extent that the cancers grow in the face of treatment
with that drug.
The two main objectives of the study are to establish
the degree to which phenoxodiol reverses chemo-resistance,
and to compare the relative efficacies of paclitaxel and
cisplatin in combination with phenoxodiol.
The treatment regime will comprise an injection of
phenoxodiol on two consecutive days, followed by a
single weekly injection of paclitaxel or cisplatin
immediately following the second phenoxodiol treatment.
This will be administered over a treatment cycle of 6 weeks,
with cycles to be repeated until a response is obtained.
Another objective of the study is to determine the dosage
of paclitaxel or cisplatin that will minimize toxicity
when used in combination with phenoxodiol.
The dosage of these two chemotherapies will be reduced
as required until toxicity no greater than Grade 1 is
achieved. Grade 1 toxicity is the lowest of 4 levels
of toxicity as defined by the National Cancer
Institute's Toxicity Classification Criterion. Toxicities
of Grade 3 or higher are commonly encountered with dosages
of such therapies required to achieve an anti-cancer effect.
Researchers believe that phenoxodiol will restore the
sensitivity of the chemo-resistant cancer cells to the e
xtent that paclitaxel and cisplatin can achieve a
significant anti-cancer effect with only minimal side-effects.
The primary clinical end-points being sought are a
reduction in tumor mass and blood levels of tumor markers
(CA 125 and CA19.9), and an improvement in clinical status
and survival at 6 and 12 months.
Phenoxodiol reverses chemo-resistance through its ability
to degrade anti-apoptotic proteins such as XIAP and
c-FLIP that serve to block the ability of tumor cells
to undergo apoptosis via the Fas death receptors.
Phenoxodiol is an investigational drug and, as such,
is not marketed in the United States.
Phenoxodiol is an investigational anti-cancer drug
developed by pharmaceutical company Marshall Edwards,
Inc., which 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