- Report of Foreign Issuer (6-K)
March 18 2009 - 7:50AM
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 March, 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
18 March, 2009
ASX
& MEDIA RELEASE
18
MARCH 2009
NOVOGEN’S
NV-128 TARGETS THE mTOR PATHWAY TO INDUCE CELL DEATH IN EPITHELIAL OVARIAN
CANCER STEM CELLS
(Sydney,
Australia and New Canaan, Connecticut) – NV-128, a Novogen Limited (ASX:
NRT; NASDQ: NVGN) compound, induced cell death in Ovarian Cancer Stem Cells
(OCSCs) in a dose-dependent manner. The study will be presented by
Ayesha Alvero, M.D., of Yale University School of Medicine, Department of
Obstetrics, Gynecology and Reproductive Science, at the 2009 Annual Meeting of
the American Association for Cancer Research in Denver, 18-22 April,
2009.
Because
ovarian cancer stem cells usually survive conventional chemotherapy, these cells
are considered to be the potential source of recurrence. It appears
that NV-128 promotes cell death in these cancer stem cells through inhibition of
the mTOR pathway. These findings may open up a new avenue for
treating ovarian cancer patients who become resistant to
chemotherapy.
The team
from Yale University, headed by Professor Gil Mor, recently reported the
identification and characterisation of the epithelial ovarian cancer stem cells
using the marker CD44 and demonstrated the up-regulation of the mTOR survival
pathway in these cells. They previously reported that the synthetic
isoflavonoid compound, NV-128, is able to specifically induce mTOR
dephosphorylation resulting in inhibition of both mTORC1 and mTORC2
activity. In epithelial ovarian cancer cell lines NV-128 caused
substantial cell death in mice engrafted with human ovarian cancers, reducing
tumour growth, but more importantly, this effect was achieved without apparent
toxicity.
The
objective of this study was to determine the cytotoxic effect of NV-128 on the
ovarian cancer stem cells. NV-128 had a dramatic effect on the growth
and differentiation of CD44+ ovarian cancer stem cells. CD44+ ovarian
cancer stem cells were treated with increasing concentrations of NV-128 and
positive results were observed as early as 15 minutes
post-treatment. In addition, NV-128 prevented ovarian cancer stem
cell differentiation in the Matrigel differentiation system.
“We are
encouraged by the selective cytotoxic effects and the impact of NV-128 on
ovarian cancer stem cells,” said Professor Alan Husband, Group Director of
Research for the Novogen group.
“We have
observed similar selective cytotoxicity with NV-128 in non-small cell lung
cancer models and we look forward to the further clinical development of this
compound so that these aggressive diseases may be more safely and effectively
treated using this new opportunity presented by NV-128,” said Professor
Husband.
When
NV-128 is used in combination with the Marshall Edwards, Inc., compound
phenoxodiol, apoptosis is enhanced because two pathways to cell death appear to
be activated, according to pre-clinical studies completed in late 2008.
More information on phenoxodiol can be found at
www.ovaturetrial.com
.
To view
the abstract go to the following URL:
http://www.abstractsonline.com/viewer/?mkey=%7BD007B270%2DE8F6%2D492D%2D803B%2D7582CE7A0988%7D
and enter search term “NV-128”.
About
NV-128
NV-128
does not rely on the traditional approach of caspase-mediated apoptosis, a death
mechanism which is not effective in cancer cells that have become resistant to
chemotherapy. Rather, NV-128 uncouples a signal transduction cascade
which has a key role in driving protein translation and uncontrolled cancer cell
proliferation. Further, NV-128 induces mitochondrial depolarization via
the novel mTOR pathway. In cancer cells, mTOR signals enhance tumour
growth and may be associated with resistance to conventional therapies.
Inhibition of mTOR appears to shut down many of these survival pathways,
including proteins that protect the mitochondria of cancer
cells. Animal studies have shown that NV-128 not only significantly
retards tumour proliferation, inhibiting the progression of ovarian cancers
engrafted into mice, but produces this effect without apparent
toxicity. This effect was shown to be due to caspase-independent
pathways involving inhibition of the mTOR pathway. Unlike analogues
of rapamycin, which target only mTORC1, NV-128’s capacity to
inhibit mTOR enables it to inhibit both mTORC1 and mTORC2
activity. This blocks growth factor-driven activation of AKT and the
potential for development of chemoresistance.
About
Novogen Limited
Novogen
Limited (ASX: NRT; NASDAQ: NVGN) is an Australian biotechnology company based in
Sydney, Australia, that is developing a range of oncology therapeutics from its
proprietary flavonoid synthetic chemistry technology
platform. Marshall Edwards, Inc. (Nasdaq: MSHL) is a majority owned
US subsidiary of Novogen which has licensed rights from Novogen to undertake
clinical trials to bring three of its oncology drugs - phenoxodiol, triphendiol
(NV-196) and NV-143 - to market globally. More information on
phenoxodiol, triphendiol, NV-128 and on the Novogen group of companies can be
found at
www.novogen.com
and
at
www.marshalledwardsinc.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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