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 June, 2009
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
17 June, 2009
ASX
& MEDIA RELEASE
17
JUNE, 2009
INDEPENDENT
DATA MONITORING COMMITTEE REVIEWS MARSHALL EDWARDS, INC.’S ARRANGEMENTS FOR DATA
ANALYSIS OF THE OVATURE TRIAL
Novogen
Limited’s subsidiary, Marshall Edwards, Inc., (NASDAQ: MSHL) has just made the
following announcement.
New
Canaan, Connecticut., 17 June, 2009 - The Independent Data Monitoring Committee
(IDMC) created to oversee the conduct of the Phase III
OVA
rian
TU
mor
RE
sponse (OVATURE) Trial,
which convened during the recent Annual Meeting of the American Society of
Clinical Oncology, considered the data accumulated to date and reviewed the
arrangements announced by the Company for early termination of patient enrolment
into the study.
The IDMC
reviewed available unblinded data from 117 subjects and noted that, at the time
of termination of recruitment, 142 subjects had been randomised to the
study.
The IDMC
supported the Company’s decision to close the study to accrual, and, in a review
of the available safety data, the IDMC confirmed that there were no safety
concerns with phenoxodiol in these subjects. Consistent with the IDMC
charter, the Company will convene an expert committee to review the IDMC
recommendations including those with respect to the disposition of subjects
remaining in the OVATURE study.
The IDMC
recommended that the final analyses be completed as soon as
possible. A full review of the outstanding tasks now indicates that
completion of data collection and database lock will likely require a further
six months for analysis of the primary efficacy endpoint of Progression Free
Survival. At that stage, a number of pre-specified subset analyses
will also be performed.
The IDMC
was advised that, since the tasks to achieve full study completion and database
lock were now clearly defined, the previous Clinical Services Agreement has been
terminated and a new contract is being established for the final stages of data
collection and site close-out. This is being offered by way of tender
to a number of Contract Research Organisations, to ensure the study is completed
as quickly and as efficiently as possible.
The
OVATURE trial is a major multi-centre international Phase III clinical trial of
orally-administered investigational drug 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 recruited ovarian cancer patients whose cancer initially responded
to chemotherapy, but had since become resistant or refractory to traditional
platinum treatments. The trial was approved by the U.S. Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA) program, and the
protocol provided for an analysis of interim results after 95 of the planned 340
recruited patients experienced disease progression. It is
anticipated that analyses after the early termination of recruitment following
randomisation of 142 patients will yield results from a greater number of
progressed patients than was required for the planned interim
analysis.
About
phenoxodiol:
Phenoxodiol
is being developed as a chemosensitizing agent in combination with platinum
drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for
prostate and cervical cancers. It is believed to have 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,
inducing cancer cell death via caspase expression and promoting sensitivity to
other chemotherapeutics. 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
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 U.S. 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.
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 characterised 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
(ASX: NRT - NASDAQ: NVGN) to bring three oncology drugs – phenoxodiol,
triphendiol and NV-143 – to market globally. Marshall Edwards, Inc.
is majority owned by Novogen, an Australian biotechnology company that is
specialising in the development of therapeutics based on a flavonoid technology
platform. 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 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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