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 May, 2007
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
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
1 May, 2007

ASX
& MEDIA RELEASE
2
MAY, 2007
Novogen
Limited’s subsidiary, Marshall Edwards Inc. (NASDAQ: MSHL), has made the
following announcement:
NEW
RESEARCH RESULTS SHOW THAT INVESTIGATIONAL DRUG
PHENOXODIOL
TARGETS CANCER PROTEIN, CAUSING CANCER CELL DEATH
Worldwide
pivotal phase III study in women with recurrent ovarian cancer underway
(Sydney,
Australia and Washington, DC - 1 May, 2007) A new study further supports the
unique mechanism of action of phenoxodiol, an investigational drug being studied
for the treatment of ovarian cancer. The drug appears to work by targeting
a
certain tumour-specific protein, which triggers a series of events that
selectively induce cancer cell death. Phenoxodiol is currently being studied
in
patients with resistant ovarian cancer, a disease that is estimated to kill
more
than 15,000 women this year in the U.S. alone.
In
studies conducted thus far, phenoxodiol has exhibited an excellent safety
profile, with few patients experiencing side effects attributed to the
drug.
The
new
research was conducted by a team headed by Research Professor Michael Berridge
Ph.D., at the Malaghan Institute of Medical Research — New Zealand’s leading
medical research facility focused on finding cures for cancer and other
diseases.
Findings
from the study, to be presented at the New Zealand Society of Oncology meeting
to be held May 9-11, help explain the mechanism by which phenoxodiol induces
cancer cell death. This new research supports previous findings by Professor
James Morré, Ph.D. at Purdue University, which showed that phenoxodiol interacts
with the tumour-specific protein, tNOX, to selectively block cancerous cells
from dividing and switching off a variety of pro-survival signalling mechanisms
within the cancer cell, causing it to die.
In
cases
of late-stage ovarian cancer, standard chemotherapy drugs often have a limited
duration of use. The cancer can progressively lose its sensitivity to
chemotherapy until cancer cells become unresponsive causing resistance, a major
barrier to successful cancer treatment. In laboratory studies and Phase II
clinical trials, phenoxodiol showed promise in restoring drug sensitivity to
resistant cancer cells.
“Phenoxodiol
has a unique mechanism of action not exhibited by other anticancer drugs in
current use.,” said Dr. Berridge. “By inhibiting plasma membrane electron
transport selectively in cancer cells, phenoxodiol subjects these cells to
stress that leads to cell death. This novel drug and its related analogues
have
the potential to enhance anticancer efficacy by a different mechanism, promising
a new approach to management of solid tumours in a range of clinical settings.
As the first compound to operate via this pathway, confirmatory evidence to
validate the mechanism of action is very desirable.”
Specific
findings identify specific proteins associated with unlocking the mystery for
why cancer cells don’t die the way healthy cells do.
Evidence
from this new study indicates that phenoxodiol inhibits proliferation of many
cancer cell lines and some primary immune cells. Phenoxodiol induces the
destruction of cancer cells by disrupting a stress pathway in the outer cell
membrane, causing down regulation of the FLICE-inhibitory protein, FLIP, and
resulting in caspase-dependent and independent degradation of the X-linked
inhibitor of cell death, XIAP.
Phenoxodiol
selectively limits plasma membrane electron transport in cancer cells, by
binding to a cancer specific surface plasma membrane electron transport element
on cancer cells thereby inhibiting their proliferation, whereas the compound
has
no such effect on normal healthy cells.
Multinational
trial underway
Phenoxodiol
in combination with carboplatin is currently being studied in a
multi-national Phase III clinical trial called OVATURE, following positive
findings of previous trials conducted at Yale-New Haven Hospital. The OVATURE
trial will take place in 60 sites in the United States, Europe, and Australia.
Preliminary results from the trial are expected within 18 months.
About
phenoxodiol:
Phenoxodiol
is being developed as a therapy for late-stage, chemo-resistant prostate,
ovarian and cervical cancers. Phenoxodiol is an investigational drug and, as
such, is not commercially available. It is a novel-acting drug that inhibits
key
pro-survival signalling 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 tumour cells to undergo apoptosis in
response to chemotherapy. The putative molecular target for phenoxodiol is
a
tumour-specific protein, accounting for the highly selective nature of the
drug.
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 efficacy against a range of cancer targets with
few side effects. The unique combination of efficacy and safety has been
explained by their ability to target an enzyme present on the surface 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, 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.