Novogen Ltd - Report of Foreign Issuer (6-K)
January 08 2008 - 6:02AM
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
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):
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
7
January,
2008
ASX
& MEDIA RELEASE
7
JANUARY, 2008
GLYCOTEX,
INC., OBTAINS ACTIVE IND FROM US FOOD AND DRUG ADMINISTRATION FOR GLYC-101
WOUND
HEALING COMPOUND.
Novogen
Limited (ASX: NRT NASDAQ: NVGN), announced today that its 81 per cent
owned US subsidiary company Glycotex, Inc., obtained an active Investigational
New Drug Application (IND) from the US Food and Drug Administration (FDA)
for
the start of a phase IIa clinical trial of its lead product candidate GLYC-101,
administered topically for the treatment of burn wounds.
The
phase
IIa human clinical trial to be conducted in the US is randomised double-blind,
placebo controlled clinical trial designed to investigate the safety and
clinical outcomes of topically applied GLYC-101 compared to placebo in subjects
undergoing carbon dioxide laser skin resurfacing.
GLYC-101
has already completed a phase II human clinical trial in Australia for the
treatment of chronic venous skin ulcers. Glycotex Inc intends to
develop GLYC-101 for a wide range of human wound healing and tissue repair
applications including burn wounds, post surgical wounds, diabetic ulcers
and
chronic venous ulcers.
About
Glycotex, Inc:
Glycotex,
Inc., is a US based
development stage biopharmaceutical company focused on discovering and
developing therapies intended to accelerate human wound healing and tissue
repair across a wide range of human applications. It has licensed
from Novogen certain patent rights and knowhow to use and exploit its technology
in a wide range of wound healing applications.
Glycotex,
Inc., is an 81per cent owned
subsidiary of Novogen Limited.
For
more information, visit
www.glycotexinc.com
About
Novogen Limited:
Novogen
Limited (ASX:
NRT NASDAQ: NVGN) is an Australian biotechnology company that has
patented isoflavones and glucan technologies for the treatment and prevention
of
degenerative diseases and disorders. 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 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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