UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
______________________________________________
Form
6-K
REPORT
OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE
SECURITIES
EXCHANGE ACT OF 1934
For the
month of May 2008
Commission
File Number
________________
Novogen
Limited
(Translation
of registrant’s name into English)
140 Wicks
Road, North Ryde, NSW, 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
x
Form 40-F
o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(l):
o
Note:
Regulation S-T Rule 101 (b)( I) only permits the submission in paper of a Form
6-K if submitted solely to provide an attached annual report to security
holders.
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule lO1(b)(7):
o
Note:
Regulation S-T Rule l01(b)(7) only permits the submission in paper of a Form 6-K
if submitted to furnish a report or other document that the registrant foreign
private issuer must furnish and make public under the laws of the jurisdiction
in which the registrant is incorporated, domiciled or legally organized (the
registrant’s “home country”), or under the rules of the home country exchange on
which the registrant’s securities are traded, as long as the report or other
document is not a press release, is not required to be and has not been
distributed to the registrant’s security holders, and, if discussing a material
event, has already been the subject of a Form 6-K submission or other Commission
filing on EDGAR.
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 l2g3-2(b) under the Securities Exchange Act of 1934. Yes
o
No
x
If “Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
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)
/s/ Ron
Erratt
Ronald
Lea Erratt
Company
Secretary
Date
9 May, 2008
ASX
& MEDIA RELEASE
9
MAY, 2008
EXTENDED
ACCRUAL TIME AND DECREASED SAMPLE SIZE FOR OVATURE, A MULTINATIONAL PHASE III
CLINICAL STUDY FOR WOMEN WITH RECURRENT OVARIAN CANCER
Novogen
Limited’s subsidiary, Marshall Edwards Inc., (NASDAQ: MSHL), has made the
following announcement:
Sydney,
Australia; London, UK and New Canaan, Connecticut. The accrual
time for the
OVA
rian
TU
mor
RE
sponse (OVATURE) clinical
study, a Phase III study of the investigational chemosensitising drug,
phenoxodiol, has been extended to facilitate complete patient enrolment in the
US, Europe, and Australia. Increasing the accrual period allowed
decreasing the total number of patients in the study, without changing the
required statistical analyses. As a result, the OVATURE study will
enrol 340 patients at 60 – 80 clinical sites throughout the United States,
Europe, and Australia. Initially, this study was announced to enrol
470 patients.
The
primary outcome of the OVATURE trial is the assessment of the relative time it
takes for the ovarian cancer to progress. The OVATURE trial design
has been approved by the US Food and Drug Administration (FDA) under a Special
Protocol Assessment (SPA) program, and provides for an interim analysis of the
data, which, if statistically significant, can be used to support a request for
accelerated marketing approval. An analysis of interim results will
be possible after patient recruitment to this study is completed and 95 patients
have disease progression.
Phenoxodiol
is being developed by the US oncology company Marshall Edwards, Inc. (NASDAQ:
MSHL) as a novel therapeutic in combination with carboplatin for late-stage
chemoresistant ovarian cancers, as well as a monotherapy for prostate and
cervical cancers. Phenoxodiol is an investigational novel-acting drug
that inhibits key pro-survival signalling pathways operating within cancer cells
causing selective cancer cell death and increased susceptibility to drugs like
platinum and taxane, to which most ovarian cancer patients become resistant in
late stage disease.
The
OVATURE trial is a major multi-centre multinational Phase III clinical trial of
orally-administered phenoxodiol in combination with carboplatin in women with
advanced ovarian cancer resistant or refractory to platinum-based drugs, to
determine its safety and effectiveness when used in combination with
carboplatin. The OVATURE trial is recruiting ovarian cancer patients
whose cancer initially responded to chemotherapy, but has since become resistant
or refractory to traditional platinum treatments. Patients are being
recruited at clinical sites across USA, UK, Europe and
Australia. Currently, more than 25 sites in the US, 20 sites in
Europe/UK, and five sites in Australia are participating in this clinical
study.
Patients
and caregivers who are interested in learning more about the OVATURE trial
should visit a website for this study at
www.OVATUREtrial.com
.
About
phenoxodiol:
Phenoxodiol
is being developed as a chemosensitising agent in combination with platinum
drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for
prostate and cervical cancers. It has a unique mechanism of action,
binding to cancer cells via a cell membrane oxidase, causing major downstream
disturbances in expression of proteins necessary for cancer cell survival and
responsible for the development of drug resistance.
In cancer
cells, phenoxodiol appears to selectively inhibit the regulator known as S-1-P
(sphingosine-1-phosphate) that is over expressed in cancer cells. In
response to phenoxodiol, the S-1-P content in cancer cells is decreased, with a
consequent decrease in expression of the pro-survival proteins XIAP and FLIP,
rendering those cells more sensitive to chemotherapy. Indeed, in
laboratory studies, it has been demonstrated that drug-resistant ovarian cancer
cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy
drugs.
Importantly,
phenoxodiol has been shown not to adversely affect normal cells in animal and
laboratory testing.
Phenoxodiol
is being investigated as a therapy for late-stage, chemoresistant ovarian,
prostate and cervical cancers. Phenoxodiol has received Fast Track
status from the FDA to facilitate its development as a therapy for recurrent
ovarian and prostate cancers.
Phenoxodiol
is an investigational drug and, as such, is not commercially
available. Under US law, a new drug cannot be marketed until it has
been investigated in clinical trials and approved by FDA as being safe and
effective for the intended use.
Phenoxodiol
is the first of a family of compounds in the Marshall Edwards, Inc.’ drug
pipeline of flavanoid derivatives.
About
Marshall Edwards, Inc:
Marshall
Edwards, Inc. (NASDAQ: MSHL) is a specialist oncology company focused on the
clinical development of novel anti-cancer therapeutics. These derive
from a flavonoid technology platform, which has generated a number of novel
compounds characterized by broad ranging activity against a range of cancer cell
types with few side effects. The combination of anti-tumour cell
activity and low toxicity is believed to be a result of the ability of these
compounds to target an enzyme present in the cell membrane of cancer cells,
thereby inhibiting the production of pro-survival proteins within the
cell. Marshall Edwards, Inc. has licensed rights from Novogen Limited
(NASDAQ: NVGN) to bring three oncology drugs – phenoxodiol, triphendiol and
NV-143 – to market globally. The Company's lead investigational drug,
phenoxodiol, is in a Phase III multinational multi-centred clinical trial for
patients with recurrent ovarian cancer. More information on the trial
can be found at
http://www.OVATUREtrial.com
.
Marshall
Edwards, Inc. is majority owned by Novogen, an Australian biotechnology company
that is specializing in the development of therapeutics based on a flavonoid
technology platform. Novogen, based in Sydney, Australia, is
developing a range of therapeutics across the fields of oncology, cardiovascular
disease and inflammatory diseases. More information on phenoxodiol
and on the Novogen group of companies can be found at
www.marshalledwardsinc.com
and
www.novogen.com
.
Under
US 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 management's 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.
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