- Report of Foreign Issuer (6-K)
January 07 2009 - 6:09AM
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 January, 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
7 January, 2009
ASX
& MEDIA RELEASE
8
JANUARY, 2009
MARSHALL
EDWARDS, INC. GRANTED IND FOR TRIPHENDIOL
Novogen
Limited’s subsidiary, Marshall Edwards, Inc., (NASDAQ: MSHL) has just made the
following announcement.
New
Canaan, Connecticut, 7 January, 2009 – Marshall Edwards, Inc. today announced
that it has been granted an Investigative New Drug (IND) approval by the United
States Food and Drug Administration to undertake clinical studies with
triphendiol as a chemosensitising agent in combination with
gemcitabine. This approval will enable a Phase Ib study of
triphendiol in combination with gemcitabine in patients with unresectable,
locally advanced or metastatic pancreatic and bile duct cancers.
About
Triphendiol
Triphendiol
(NV-196) is an investigational drug in the Marshall Edwards, Inc., oncology drug
pipeline, currently being developed as an orally-delivered chemosensitising
agent, intended for use in conjunction with standard chemotoxic anti-cancer
drugs for the treatment of late stage pancreatic cancer, cholangiocarcinoma, and
melanoma. Triphendiol was granted orphan drug status by the US Food
and Drug Administration for pancreatic cancer and cholangiocarcinoma in January,
2008 and for treatment of stage IIb-IV malignant melanoma in February,
2008.
Triphendiol
is broadly cytostatic and cytotoxic against most forms of human cancer cells in
vitro, and has been shown to cause cell cycle arrest (or stop cells increasing
in number) and to induce apoptosis (or initiate programmed cell death) in
various cancer cell lines. Biological studies suggest a mechanism of
cytotoxicity that involves mitochondrial depolarisation and downregulation of
XIAP. It exhibits high selectivity, little effect on non-tumour cells
and no observable toxicity in animals at therapeutically effective
doses. In human studies conducted in Australia, no adverse events or
side effects have been reported when administered to volunteers.
About
Marshall Edwards, Inc:
Marshall
Edwards, Inc. 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
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 in the cell membrane of cancer cells, thereby
inhibiting the production of pro-survival proteins within the
cell. Marshall Edwards, Inc. has licensed rights from Novogen Limited
(ASX: NRT 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
.
Marshall
Edwards, Inc. is majority owned by Novogen (ASX: NRT, NASDAQ: NVGN), an
Australian biotechnology company that is specialising in the development of
therapeutics based on a flavonoid technology platform. Novogen 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 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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