- Report of Foreign Issuer (6-K)
October 29 2008 - 6:59AM
Edgar (US Regulatory)
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 October, 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
29 October, 2008
ASX
& MEDIA RELEASE
29
OCTOBER, 2008
MARSHALL
EDWARDS’ PHENOXODIOL AND NOVOGEN’S NV-128 DISPLAY DIVERGENT
MECHANISMS OF ACTION BUT POTENT SYNERGISTIC ANTI-CANCER ACTIVITY WHEN USED IN
COMBINATION
Pre-clinical
studies presented at the 9th International Conference on Membrane Redox Systems
in Wellington New Zealand this week demonstrate that Novogen’s NV-128 (a novel
mTOR inhibitor), when used in combination with the Marshall Edwards, Inc’s.
Phase III anti-ovarian cancer drug, phenoxodiol, produces potent
synergistic anti-cancer activity against non-small cell lung carcinoma cell
lines (NSCLC). Importantly, the synergistic cytotoxicity observed
between NV-128 and phenoxodiol was superior to the synergy observed between
NV-128 and paclitaxel against NSCLC. These data were presented by Dr
David Brown, Program Manager (Cancer Biology), Novogen.
“In NSCLC
targets, these two drugs in combination produced an anti-cancer effect superior
to that achieved with either drug alone or in combination with current approved
anti-cancer cytotoxic drugs. The potential for improved efficacy,
coupled with the safety profile of these novel drugs, suggests the potential for
clinical benefits in lung cancer patients which cannot be achieved with current
standard of care drugs,” Dr Brown said.
Phenoxodiol
is being developed as a therapy for late-stage, chemoresistant prostate and
ovarian cancers. 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 and
FLIPs. Loss of activity of these proteins restores the ability of
chemoresistant tumour cells to undergo caspase-mediated apoptosis in response to
chemotherapy. The putative molecular target for phenoxodiol is a
surface oxidase which is preferentially expressed on cancer cells and is linked
to the expression of pro-survival pathways in these cells. The
ability of the drug to bind preferentially to cancer cells rather than normal
cells is reflected in its high safety profile in clinical use.
In
contrast to phenoxodiol, NV-128 does not induce caspase-mediated apoptosis, a
death mechanism which is often non-functional in chemoresistant cancer cells due
to accumulated mutations in tumour suppressor/promoter genes and over-expression
of anti-apoptotic proteins. Rather, NV-128 uncouples the
akt-mTOR-P70S6K signal transduction cascade which has a key role in driving
protein translation and uncontrolled cancer cell
proliferation. Further, NV-128 induces mitochondrial depolarisation
via a novel pathway involving the autophagy protein Beclin-1 and Bcl-2, thereby
resulting in endonuclease G translocation to the nucleus and cell
death. Importantly, when NV-128 is used in combination with
phenoxodiol, XIAP is degraded in these cells allowing the caspase-mediated
apoptosis cascade to be engaged in addition to NV-128-endonuclease G mediated
apoptosis resulting in two pathways to cell death.
“These
data provide direct evidence that while invoking discrete modes of cell death,
NV-128 and phenoxodiol can be used synergistically to force the convergence of
caspase-mediated and caspase-independent cell death pathways to drive overall
cell death”, said Dr Brown.
About
Novogen Limited:
Novogen
Limited (ASX: NRT; NASDAQ: NVGN) is an Australian biotechnology company that has
patented isoflavone technology for the treatment and prevention of degenerative
diseases and disorders. Over the past ten years, Novogen has
conducted the largest and most comprehensive isoflavone clinical testing
programs in the world. Novogen is involved in drug discovery and
product development for a range of degenerative disorders including cancer,
cardiovascular diseases and inflammatory diseases. The Company
coordinates an international clinical research and development program with
external collaborators, hospitals and universities. For more
information, visit
www.novogen.com
.
About
Marshall Edwards, Inc:
Marshall
Edwards, Inc. (NASDAQ: MSHL) is majority owned by Novogen It as a
specialist oncology company focused on the clinical development of novel
anti-cancer therapeutics derived from the flavonoid technology
platform. This platform has generated a number of novel anti-cancer
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 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, 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
.
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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