Novogen Ltd - Report of Foreign Issuer (6-K)
March 13 2008 - 7:17AM
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, 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
13 March, 2008
ASX
& MEDIA RELEASE
13
MARCH, 2008
GLYCOTEX
COMPLETES ENROLMENT IN PHASE IIA STUDY OF LEAD PRODUCT CANDIDATE GLYC-101 FOR
WOUND HEALING
Novogen
Limited’s US subsidiary, Glycotex, Inc., has made the following
announcement:
Rockville,
MD – Thursday, March 13, 2008 - Glycotex, Inc. today announced that it had
completed patient enrolment in a Phase IIa study evaluating the effect of
GLYC-101 on wound closure in patients undergoing carbon dioxide laser skin
resurfacing.
The
randomised, double-blind, placebo-controlled clinical study in Beverly Hills,
California has enrolled 12 patients undergoing laser skin
ablation. In addition to assessing safety endpoints, the study is
investigating efficacy endpoints, among them the promotion of wound healing and
cosmetic outcomes.
About
GLYC-101
GLYC-101is
intended to stimulate and modulate the natural cascade of wound healing
activities of several cell populations. The product candidate is a topical
gel to be applied directly on the wound surface. In May 2006, Glycotex
completed a Phase II clinical trial of GLYC-101 in Australia, in which
GLYC-101 produced a statistically significant rate of wound area reduction
versus combined placebo and standard care in patients with chronic venous
ulcers. The results provided proof-of concept and dose-ranging
information for GLYC-101.
The
strategic priorities for GLYC-101 include wound healing following laser
ablation, burn wounds, surgical wounds, venous ulcers and diabetic
ulcers.
About
Glycotex, Inc.
Glycotex,
Inc. is a U.S. 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 Limited certain patent rights and know-how to use and
exploit its technology in a wide range of wound healing
applications. Glycotex, Inc. is an 81 percent owned subsidiary of
Novogen Limited. For more information, visit
www.glycotexinc.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 of our products to obtain such approval,
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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