- Report of Foreign Issuer (6-K)
March 18 2009 - 7:52AM
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, 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
18 March, 2009
ASX
& MEDIA RELEASE
19
MARCH, 2009
TRIPHENDIOL
SAFETY DATA CLEARS THE WAY FOR TRIPHENDIOL TO BE STUDIED FURTHER IN THE
TREATMENT OF PANCREATIC CANCER
Novogen
Limited’s subsidiary, Marshall Edwards, Inc., (NASDAQ: MSHL) has just made the
following announcement:
New
Canaan, Connecticut, 18 March, 2009 - Marshall Edwards, Inc., (Nasdaq:
MSHL). An abstract will be presented at the Annual Meeting of the
American Association for Cancer Research, April 18-22 in Denver showing that
triphendiol has an acceptable toxicity profile in animals. The
abstract (#1935) is titled “Pre-clinical Toxicology of Triphendiol
(NV-196).”
Triphendiol
was granted orphan drug status by the US Food and Drug Administration (FDA)for
pancreatic cancer and cholangiocarcinoma in January, 2008 and for treatment of
stage IIb-IV malignant melanoma in February, 2008. In January 2009
triphendiol was granted an Investigative New Drug (IND) approval by the US FDA
to undertake clinical studies with triphendiol as a chemosensitizing agent in
combination with gemcitabine.
The
abstract, to be presented by Dr Wasif Saif, Associate Professor and Co-Director,
Gastrointestinal Cancers Program, Yale School of Medicine, summarises data from
a number of preclinical studies performed in order to obtain data to support the
IND filing. In
in
vitro
studies triphendiol was non-mutagenic in the bacterial reverse
mutation assay (Ames test) and non-clastogenic in the mouse erythrocyte
micronucleus assay. Studies in animals indicated not only acceptable
pharmacokinetics, but also no accumulation of triphendiol when administered to
animals in repeated doses. Also there were no toxicologically
important changes in clinical signs, body weights, hematology, coagulation time,
serum chemistry, urinalysis, gross observations, organ weights or histologic
findings for any study animal. There were no significant changes to
heart rate and the Q-T segment interval indicating a lack of cardiovascular
toxicity
There is
an urgent need for new pancreatic cancer treatments because fewer than 20
percent of patients are candidates for surgery
(pancreotectomy). Current treatment is limited to chemotherapy with
gemcitabine, to which most patients are resistant or acquire
resistance. A study presented at AACR’s 2008 Annual Meeting assessed
the potential of triphendiol as a treatment for pancreatic adenocarcinoma, using
three representative cell lines. Triphendiol induced apoptosis (cell
death) in all cell lines and pre-treatment with triphendiol increased
gemcitabine-dependent apoptosis. Animal model studies showed that
triphendiol in combination with gemcitabine inhibits tumour growth more
effectively than each drug alone. Both triphendiol and gemcitabine
induce apoptosis via a mitochondrial pathway.
Laboratory
testing
in vitro
and in
animals bearing human pancreatic and bile duct tumours has demonstrated
selective activity of triphendiol against cancer cells. In mice
bearing a human pancreatic cancer tumour, triphendiol administration resulted in
a mean reduction in tumour volume by 62 percent compared with untreated control
animals. In the two Phase I clinical studies completed thus far, the
investigational drug has demonstrated acceptable pharmacokinetic profiles in
human volunteers with no reported side effects.
Professor
Alan Husband, Group Director of Research for Marshall Edwards, said, "This study
is further evidence that triphendiol has an acceptable toxicity profile.
This creates a strong foundation for our clinical development program for
triphendiol as a safer multi-potent anti-cancer agent than current treatments
for pancreatic and bile duct cancers.”
"We are
hopeful that triphendiol will continue to show benefit in unusually aggressive
and difficult-to-treat diseases such as pancreatic cancer," Professor Husband
said.
Pancreatic
cancer is considered an "orphan" cancer, because of its relatively low incidence
and high mortality. It is slightly more common in men than in
women. In the US it is the fourth leading cause of cancer-related
death in men and the fifth leading cause of cancer-related deaths in women with
a death rate estimated by the National Cancer Institute of approximately 96
percent of patients with the disease. The estimated number of new
cases of pancreatic cancer in the US in 2008 was 37,680, with 34,290 deaths
caused by the disease
according
to the National Cancer Institute. Pancreatic cancer has a poor
prognosis. The disease is difficult to diagnose in its early stage,
and patients usually present with incurable disease. It has a high
mortality rate, and no therapy has been shown to significantly impact
survival.
About triphendiol
Triphendiol
(NV-196) is another investigational drug in the Marshall Edwards 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 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
depolarization 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 so far, no
adverse events or side effects have been reported when administered to
volunteers.
About Marshall Edwards, Inc. and
Novogen Limited
Marshall
Edwards is a specialist oncology company focused on the clinical development of
novel anti-cancer therapeutics. These derive from a flavonoid
technology platform that has generated a number of novel compounds characterised
by broad ranging activity in laboratory testing against a range of cancer
targets with few side effects. The ability of these compounds to
target an enzyme present on the surface of cancer cells, and inhibit the
production of pro-survival proteins within the cancer cell suggests that they
may possess a unique combination of efficacy and safety. Marshall
Edwards has licensed rights from Novogen Limited (ASX: NRT; NASDAQ: NVGN) to
bring three oncology drugs - phenoxodiol, triphendiol (NV-196) and NV-143 - to
market globally. Marshall Edwards is majority owned by Novogen, an
Australian biotechnology company that is specialising in the development of
therapeutics based on a flavonoid technology platform. Novogen, based
in Sydney, Australia, is developing a range of oncology therapeutics from its
proprietary flavonoid synthetic chemistry technology platform. More
information on phenoxodiol, triphendiol 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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