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 April, 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
14 April, 2008
ASX
& MEDIA RELEASE
13
APRIL, 2008
MARSHALL
EDWARDS, INC.’S INVESTIGATIONAL DRUG TRIPHENDIOL
(NV-196)
DEMONSTRATES POTENT ACTIVITY AGAINST BILIARY CANCERS
Novogen
Limited’s subsidiary, Marshall Edwards Inc., (NASDAQ: MSHL), has made the
following announcement:
San Diego
– 13 April - Pre-clinical studies presented here today at the annual meeting of
the American Association for Cancer Research, demonstrate that Marshall Edwards,
Inc.’s investigational drug candidate triphendiol (NV-196) induces apoptosis in
pancreatic and bile duct cancer cell lines, and also retards tumour
proliferation in animal models of both indications. Of significance,
triphendiol also potently sensitizes pancreatic and bile duct cancer cell lines
and xenograft tumours to the standard of care drug,
gemcitabine. These data were presented by Ewan Tytler, PhD, Assistant
Professor, Division of General Surgery, Gastroinstestinal Section, University of
Alabama at Birmingham (UAB), as part of a “late breaking” poster
session.
“In
laboratory studies, triphendiol is more potent at apoptosis induction in
pancreatic and bile duct cancer cells compared to gemcitabine at up to ten-fold
lower concentrations,” said Dr Tytler.
There is
an urgent need for new pancreatic cancer treatments because fewer than 20
percent of patients are candidates for surgery. Current treatment is
limited to chemotherapy with gemcitabine, to which most patients are resistant
or acquire resistance. This study 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.
Structurally,
triphendiol is an analogue of phenoxodiol, both of which are investigational
drugs that have been licensed by Novogen to Marshall Edwards,
Inc. Phenoxodiol is currently in Phase III clinical development for
patients with late stage ovarian cancer under the OVATURE
banner. Triphendiol has recently been granted orphan drug status by
the FDA for pancreatic cancer, bile duct cancer and melanoma.
Like
phenoxodiol, triphendiol is also able to induce apoptosis however, triphendiol
induced cell death is thought to proceed via both caspase-dependent and
caspase-independent pathways. In pancreatic cancer cells, triphendiol
causes up-regulation of p21 thereby arresting the cell cycle in G2M leading to
apoptosis induction. Integral to triphendiol-induced apoptosis
induction is mitochondrial depolarization due to transitory changes is Bcl-2 and
Bid expression. Like phenoxodiol, triphendiol also causes XIAP
degradation. In bile-duct cancer cells, triphendiol induces apoptosis
that is completely caspase-independent. Animal studies using nude
mice bearing human pancreatic and bile duct tumours, demonstrated that oral
triphendiol administration in combination with gemcitabine resulted in a mean
reduction in tumour volume by 62 percent and 81 percent respectively compared
with untreated tumours from control animals.
“With a
lack of data from randomized Phase III studies, there is no current
evidence-based treatment recommendation for patients with advanced pancreatic
cancer that have failed first-line gemcitabine,” said Wasif Saif, MD, Associate
Professor and Director, Gastrointestinal Cancers Program, the Yale School of
Medicine. “The ability of triphendiol to sensitize pancreatic cancer tumours to
gemcitabine in animal studies justifies the continued development of triphendiol
as a pancreatic cancer therapy, and would provide a welcome second-line
therapeutic contingency for late stage gemcitabine refractory pancreatic cancer
patients.”
Professor
Alan Husband, Group Director of Research for Marshall Edwards, Inc. said “The
commercial potential of the flavonoid technology platform from which these
candidate molecules have been derived is now becoming evident. Through continued
refinement of our proprietary molecular scaffold, we anticipate further
enrichment of our pipeline with analogues whose activity may be directed against
a diverse array of cancer targets”.
About
Phenoxodiol and Triphendiol
Phenoxodiol
is being developed as a therapy for late-stage, chemo-resistant prostate,
ovarian and cervical cancers. It is a novel-acting drug that
inhibits key pro-survival signalling pathways operating via
sphingosine-1-phosphate and Akt. Inhibition of these pathways
leads to prevention of phosphorylation of key anti-apoptotic proteins such as
XIAP and FLIPs. Loss of activity of these proteins restores the
ability of chemoresistant tumour cells to undergo apoptosis in response to
chemotherapy. The molecular target for phenoxodiol is an oxidase
enzyme present on the surface of cancer cells, accounting for the highly
selective nature of the drug.
Triphendiol
is being developed as a therapy for late state pancreatic and bile duct cancer
and has recently been awarded orphan drug status. Triphendiol-induced
apoptosis is initiated by mitochondrial depolarization due to transitory changes
is Bcl-2 and Bid expression. Like phenoxodiol, triphendiol also
causes XIAP degradation.
Multinational
Trial Underway
Phenoxodiol
in combination with carboplatin is currently being studied in
a multi-national Phase
III clinical trial called the OVATURE (
OVA
rian
TU
mour
RE
sponse) Trial, following
positive findings of previous trials conducted in Australia and at Yale-New
Haven Hospital. The OVATURE trial is taking place at over 70 clinical
sites in the United States, Europe, and Australia. For more
information on the trial, visit
www.OVATUREtrial.com
.
About
Marshall Edwards Inc:
Marshall
Edwards, Inc. (NASDAQ: MSHL) 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 characterized 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 on the surface of cancer cells, thereby
inhibiting the production of pro-survival proteins within the
cell. Marshall Edwards, Inc. has licensed rights from Novogen Limited
(NASDAQ: NVGN) to bring three oncology drugs – phenoxodiol, triphendiol and
NV-143 – to market globally.
Marshall
Edwards, Inc. is majority owned by Novogen, an Australian biotechnology company
that is specializing in the development of therapeutics based on a flavonoid
technology platform. Novogen, based in Sydney, Australia, 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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