6-K: Report of foreign issuer [Rules 13a-16 and 15d-16]
Published on
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
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
4 December, 2007
ASX
& MEDIA RELEASE
5
DECEMBER, 2007
NOVOGEN’S
INVESTIGATIONAL DRUG FOR INFLAMMATORY BOWEL DISEASE HAS POSITIVE RESULTS
FOLLOWING PHASE 1B TRIAL
In
a
recently completed Phase Ib clinical trial of a new drug to treat inflammatory
bowel disease (IBD) indicates that treatment may be possible with just a
single
daily dose.
The
drug,
NV-52, is a novel compound being developed by Australian pharmaceutical company
Novogen Limited (ASX: NRT - Nasdaq: NVGN), as an oral agent for the
maintenance of remission in IBD.
IBD
is a
debilitating illness which comprises two syndromes – ulcerative colitis
involving mainly the colon and Crohn’s disease which can affect the entire
gastrointestinal tract. IBD sufferers experience periods of
diarrhoea, bleeding, pain and extreme fatigue, and in intractable cases may
require surgical resection of portions of the bowel.
IBD
is
characterised by periods of remission, during which symptoms are controlled
by a
variety of drugs. However, relapse where symptoms recur is very
common and often needs hospitalisation. There is no cure for IBD, and
currently available medications are unable to prevent disease ‘flares’ . As
well, all therapies have side effects which compromise quality of life
significantly.
The
NV-52
Phase Ib study was conducted under the direction of clinical pharmacologist,
Professor Laurie Howes, Professor of Pharmacology and Therapeutics at Griffith
and Bond Universities
In
this
latest study, NV-52 was administered just once daily over a seven day period
to
nine healthy volunteers. During that time, the levels of NV-52 were
measured in the blood, and a wide range of safety assessments
undertaken.
Following
this once daily dosing regime, concentrations of NV-52 were maintained in
the
plasma of the volunteers at the level associated with suppression of colitis
in
the mouse model of IBD. This suggests that if the drug can be
demonstrated to be effective in humans, only once daily dosing of NV-52 would
be
required to enable control of symptoms in IBD patients. Importantly,
there were no adverse events and no side effects reported during the
study.
“These
results indicated that oral therapy with just one dose of NV-52 each day
would
provide plasma levels in IBD patients that were similar to those which were
effective in mice,” Professor Howes said. “Furthermore, chronic
dosing with NV-52 caused no abnormalities in any of the volunteers, confirming
NV-52’s excellent safety profile. Further studies are now appropriate
to determine whether NV-52 is effective in maintaining remission in IBD
patients.”
Program
Leader of the Novogen Anti-inflammatory and Cardiovascular Drug Research
Program, Dr Cath Walker, said “These data suggest that NV-52 appears to be
a safe and non-toxic therapy which, if proven to be effective in humans,
will
enable the prolonged maintenance of remission in IBD in the absence of drug
side
effects”.
NV-52
is
a synthetic phenolic derivative. NV-52 given orally is protective in
a mouse model of colitis, where it has been effective at not only reducing
the
severity of acute inflammation in the bowel, but at inhibiting its
initiation. Formal toxicology testing has demonstrated that NV-52 is
a completely non-toxic compound, causing no adverse effects in animals, as
well
as no genotoxic or mutagenic effects.
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 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.