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 May 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
15 May, 2008
ASX
& MEDIA RELEASE
16
MAY, 2008
CLINICAL
PHASE I STUDY REPORT OF MARSHALL EDWARDS’ COMPOUND TRIPHENDIOL TO BE REPORTED IN
ASCO PROCEEDINGS
Novogen
Limited’s subsidiary, Marshall Edwards Inc., (NASDAQ: MSHL), has made the
following announcement:
New
Canaan, Connecticut, May 15, 2008 - Marshall Edwards, Inc. (Nasdaq:
MSHL). An abstract titled “Phase Ia Safety and Pharmacokinetic Study
of Oral NV-196 in Patients with Solid Tumours” submitted to the Annual Meeting
of the American Society of Clinical Oncology (ASCO), 30 May to 3 June, Chicago,
Illinois, is now available at
www.asco.org
(Abstract# 14615). This reports on a human clinical study of oral
triphendiol which demonstrated a good safety profile and successful
pharmacokinetics. The trial was conducted by Professor Paul Mainwaring at the
Brisbane Mater Adult Hospital in Brisbane, Australia.
NV-196,
now known as 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.
Laboratory
testing
in vitro
and in
mice bearing human pancreatic, bile duct or melanoma tumours, has demonstrated
the activity of triphendiol against these 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.
Professor
Alan Husband, Group Director of Research for Marshall Edwards, said, "The study
being presented at ASCO is an important step towards the clinical development of
triphendiol. These data indicate that oral triphendiol appears to be
safe and can be delivered effectively in humans.”
"We will
now be well placed to apply for an Investigational New Drug (IND) approval to
continue into Phase II studies in the US later this year," Professor Husband
said.
There is
an urgent need for new pancreatic cancer treatments because fewer than 20
percent of patients are candidates for surgery
(pancreatectomy). Current treatment is limited to chemotherapy with
gemcitabine, to which most patients are resistant or acquire
resistance.
Pancreatic
cancer is considered an "orphan" cancer, because of its relatively low incidence
and high mortality. In the US, it is the fourth leading cause of
cancer-related death in men and women with the 5 year relative survival
rate of 5 percent of patients with the disease
1
. The
American Cancer Society estimated the number of new cases of pancreatic cancer
in the US in 2008 as 37,680, with 18,770 cases diagnosed in men and 18,910 in
women
1
. An
estimated 34,290 deaths from pancreatic cancer are expected in 2008
1
.
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.
Melanoma
accounts for only 3 percent of all skin cancers; however, it causes the greatest
number of skin cancer–related deaths worldwide
2
. It
is responsible for more than 77 percent of skin cancer deaths
2
. An
estimated 62,480 (34,950 men and 27,530 women) new cases with malignant
melanoma, were expected to occur only in the US in 2008
1
. An
estimated 8,420 deaths from melanoma are expected in 2008
1
.
About
Triphendiol
Triphendiol
(NV-196) is another investigational drug in the Marshall Edwards, Inc., 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
(bile duct cancer), 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, Inc. (NASDAQ: MSHL),
is a specialist oncology company focused on the clinical development of novel
anticancer therapeutics. These derive from a flavonoid technology
platform that has generated a number of novel compounds characterized by broad
ranging activity in laboratory testing against a range of cancer targets with
low toxicity. 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, Inc. 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, Inc., 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 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 US 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.
References
1
American Cancer Society: Cancer Facts and Figures 2008. Atlanta, GA: American
Cancer Society, 2008.
2 Ries
LAG, Melbert D, Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg L, Horner MJ,
Howlader N, Eisner MP, Reichman M, Edwards BK (eds). SEER Cancer Statistics
Review, 1975-2004, National Cancer Institute. Bethesda, MD,
http://seer.cancer.gov/csr/1975_2004/, based on November 2006 SEER data
submission, posted to the SEER web site, 2007.
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