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 15d-16 UNDER
THE
SECURITIES
EXCHANGE ACT OF 1934
For
the
month of November, 2006
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):
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):
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
o
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
24 November, 2006
ASX
& MEDIA RELEASE
24
NOVEMBER, 2006
Novogen
Limited’s subsidiary, Marshall Edwards Inc. (NASDAQ: MSHL), has just made the
following announcement:
FIRST
PATIENT TREATED IN PHASE III OVARIAN CANCER TRIAL
Melbourne
Australia (24 November 2006):
Marshall
Edwards Inc today announced that the first patient had commenced treatment
in
the Phase III “Ovature” clinical trial at The Royal Women’s Hospital in
Melbourne Australia.
Royal
Women’s is one of 60 hospitals which will be participating in this multi-center
multi-national ovarian cancer study to confirm the effectiveness of phenoxodiol
in resensitizing patients to chemotherapy.
Thirty
of
these hospitals will be in the US, 25 in Europe and 5 in Australia.
The
total
number of patients to be treated in this pivotal study is 470, with half
to be
on a treatment regime of phenoxodiol and the chemotherapeutic drug carboplatin,
and half on a placebo and carboplatin.
The
primary outcome of the trial is the assessment of the relative time it takes
for
the ovarian cancer to progress. An analysis of interim results will be possible
after 95 patients have progressed with their disease.
The
trial
is being run under arrangements approved by the US Food and Drug Administration
(FDA) known as a Special Protocol Assessment (SPA). This provides for the
interim analysis of the data, which if significant can be used to support
a
request for grant of marketing approval.
Professor
Michael Quinn of Royal Women’s Hospital in Melbourne said the Royal Women’s
Hospital along with the Yale University Medical School had already conducted
a
Phase II study, where phenoxodiol was shown to have a chemosensitizing effect
on
ovarian cancer when chemotherapy had previously failed.
“We
are
now hopeful that a positive outcome of this multi-center study will be a
significant medical advance for thousands of women with late stage ovarian
cancer whose tumors have become insensitive to the existing chemotherapeutic
drugs,” Professor Quinn said.
The
Chief
Executive Officer of Marshall Edwards Inc, Mr. Christopher Naughton, said
the
Phase III Ovature study was a significant milestone for the
Company.
“Over
the
next 12 to 18 months we expect the interim results from this multi-national
clinical trial which may lead to the first approval for phenoxodiol,” Mr.
Naughton said.
Mr.
Naughton said there are also other cancer types for which phenoxodiol has
shown
promise and the Company would be proceeding in the year ahead with a strategy
to
expand the drug’s utility into those other cancers as both a chemosensitizer and
as a monotherapy.
Ovarian
cancer is the most lethal gynecological malignancy and the fifth leading
cause
of cancer-related death in women in the United States. The high mortality
rate
is due mainly to the inability to detect early disease with approximately
80 per
cent of patients being diagnosed in advanced stage of disease.
About
phenoxodiol:
Phenoxodiol
is an investigational drug and, as such, is not commercially available.
Phenoxodiol is a novel-acting drug that inhibits key pro-survival signaling
pathways operating via sphingosine-1-phosphate and Akt. Inhibition of these
pathways leads to prevention of phosphorylation of key anti-apoptotic proteins
such as XIAP. Loss of activity of these proteins restores the ability of
chemoresistant tumor cells to undergo apoptosis in response to chemotherapy.
The
putative molecular target for phenoxodiol is a tumor-specific protein,
accounting for the highly selective nature of the drug.
About
Marshall Edwards Inc:
Marshall
Edwards, Inc. (Nasdaq : MSHL) has licensed rights from Novogen Limited (Nasdaq
:
NVGN) to bring three oncology drugs - phenoxodiol, NV-196 and NV-143 - to
market
globally. 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
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 arty
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.