- Report of Foreign Issuer (6-K)
December 01 2008 - 6:04AM
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 December, 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
1 December, 2008
ASX
& MEDIA RELEASE
1
DECEMBER, 2008
NOVOGEN’S
NV-128, A NOVEL mTOR INHIBITOR, SHOWS POTENTIAL ACTIVITY AGAINST CANCER STEM
CELLS
Sydney,
Australia and New Canaan, Connecticut - Pharmaceutical company Novogen Limited
(ASX: NRT Nasdaq: NVGN) today announced that work performed in collaboration
with a Yale University research team led by Associate Professor Gil Mor, MD,
PhD, has revealed its novel mTOR inhibitor NV-128 has the potential to act
against cancer stem cells in addition to rapidly proliferating cells in
established solid tumours.
“Yale’s
research team is finding that NV-128 has a high level of potency against cancer
stem cells,” said Dr Gil Mor. “In fact, of the investigational
therapies Yale has tried, NV-128 is one of the most exciting to
us.”
Published
research indicates that mTOR pathways, in addition to their involvement in
maintaining survival among rapidly dividing cells in established tumours, also
guarantee survival in cancer stem cells.
1
Cancer
stem cells are slowly dividing undifferentiated cells with capacity to
regenerate tumours rapidly after their surgical or chemical
removal. These cells are now becoming recognised as the underlying
mechanism by which tumours recur and metastasise after primary
treatment. As such they represent a promising target by which
improved cancer control may be achieved.
NV-128
has been shown to function as a potent inhibitor of the mTOR pathway and
therefore has the potential to be effective against cancer stem
cells. Novogen is now aligning its research priorities for NV-128,
and other related pipeline compounds, to look specifically at their activity in
cancer stem cells. This presents a unique opportunity to develop
NV-128, and other potential derivatives, not only for use as a therapeutic agent
in established cancers, but also to target the stem cells which lead to cancer
recurrence.
At last
year’s annual meeting of the American Association for Cancer Research, a
presentation by one of the Yale team, Associate Research Fellow Ayesha Alvero,
MD, showed in animal studies that NV-128 not only significantly retards tumour
proliferation, but is more efficacious than other standard of care drugs, and
without apparent toxicity. This effect was shown to be due to
caspase-independent pathways involving inhibition of the mTOR
pathway. But unlike analogues of rapamycin, like temsirolimus and
everolimus, which target only mTORC1, NV-128’s capacity to dephosphorylate 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.
Structurally,
NV-128 is an analogue of triphendiol and phenoxodiol, both of which are
investigational drugs that have been licensed by Novogen to Marshall Edwards,
Inc. Phenoxodiol is currently in a multinational, multi-centre Phase
III clinical trial for patients with late stage ovarian cancer (see
www.OVATUREtrial.com
). Triphendiol has recently been granted orphan drug status by the
FDA for pancreatic and bile duct cancers, and late stage melanoma.
1
Nature
Reviews - Cancer 2008 Oct;8(10):755-68. Epub 2008 Sep 11
About
NV-128
In
contrast to phenoxodiol and triphendiol, NV-128 has been shown to induce
caspase-independent DNA degradation and cancer cell death. It appears
that in conjunction with autophagy induction, NV-128 induces caspase
independent cell death via the AKT-mTOR pathway resulting in beclin
sequestration of Bcl-2, Bax up-regulation and mitochondrial
depolarisation. As a consequence, endonuclease G translocates to the
nucleus where it initiates DNA degradation and cell death. This
offers an opportunity for use as a monotherapy in chemoresistant cancers and
enhanced efficacy against cancer targets less susceptible to
phenoxodiol. The option for co-administration of combinations of
these drugs is also under investigation to extend the potential therapeutic
range of this unique class of oncology compounds.
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 disorders that are
commonly associated with aging and coordinates an international clinical
research and development program with external collaborators, hospitals and
universities. For more information, visit
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.
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