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 March, 2006
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
o
If
“Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
82-
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
29 March, 2006
ASX
& MEDIA RELEASE
29
MARCH 2006
Novogen
Limited’s subsidiary, Marshall Edwards Inc. (NASDAQ: MSHL), has just made the
following announcement:
Yale
researchers find phenoxodiol restores sensitivity to chemotherapy in some
women
with ovarian, fallopian tube or primary peritoneal cancers, in interim report
on
a phase II study
[Washington,
DC, and Sydney, Australia] March 29 — Phenoxodiol, an investigational
anti-cancer drug that is being studied by leading researchers at Yale, has
been
found to be active and to restore platinum drug sensitivity to some patients
who
have shown prior resistance to platinum-based chemotherapy agents. The
data were presented at the Annual Meeting on Women’s Cancer organized by the
Society of Gynecologic Oncology.
The
study
is designed to test the ability of phenoxodiol to reverse the resistance
that
develops in most ovarian cancers to standard chemotherapy. The study was
conducted at Yale - New Haven Hospital, Conn., USA, as well as at the Royal
Women’s Hospital, Melbourne, Australia.
“Phenoxodiol
was developed to overcome this chemical resistance within tumor cells, thereby
allowing standard anti-cancer drugs such as cisplatin, carboplatin and
paclitaxel to continue to work in this aggressive form of cancer,” said Michael
Kelly, MD, Fellow at Yale University School of Medicine. “What we are
seeing with phenoxodiol is an encouragingly high proportion of tumors either
shrinking or stabilizing with standard drugs, when we know that the tumor
is
unlikely to respond to those standard drugs alone.”
Patients
with tumor shrinkage or stabilized tumors are collectively known as having
controlled disease. The particular relevance of this outcome is that the
FDA’s
current draft guidance document suggests that prolonged survival of patients
is
a more appropriate clinical endpoint than tumor response alone. That is,
the
length of time that the tumor fails to grow, may be more meaningful in terms
of
patient survival than the incidence of tumor response on its own.
The
Yale
researchers reported that 74 percent of patients with late-stage,
platinum-resistant tumors who received the phenoxodiol and cisplatin combination
showed evidence of a change in tumor growth by way of either tumor shrinkage
or
no increase in tumor size.
The
ability of phenoxodiol to effect patient survival and progression-free survival
is to be tested in a pivotal study known as the OVATURE study, in which
phenoxodiol will be used in combination with carboplatin in patients with
tumors
that are refractory or resistant to platinum therapy.
About
ovarian cancer
Ovarian
cancer is the gynecologic cancer most likely to lead to death among women
in the
U.S., due in part to the eventual development of resistance of the tumor
to
chemotherapy. In approximately 10 to 15 percent of patients, the tumors show
a
high level of resistance to initial, standard therapy. In the remaining 85
to 90
percent of initial responders, the tumors eventually re-grow in most of these
patients due to the selection of chemo-resistant tumor cells. Ultimately
these
tumors become completely resistant to standard drugs.
The
research was conducted at Yale in collaboration with co-authors Gil Mor,
M.D.,
Lisa Baker, Jessica McAlpine, Masoud Azodi, Peter Schwartz, M.D., and Thomas
Rutherford, M.D. Participants were also recruited from the Royal Women’s
Hospital, Melbourne, Australia. Additional research was conducted at Royal
Women’s Hospital, Melbourne, Australia; Marshall Edwards, Inc., Sydney,
Australia; and at Ohio State University, Columbus, Ohio.
About
phenoxodiol
Phenoxodiol
is an investigational drug and, as such, is not marketed in the United States.
Phenoxodiol was granted fast-track status by the FDA in November 2004 for
its
intended use in women with ovarian cancer.
Phenoxodiol
is a novel acting drug that inhibits key pro-survival signaling pathways
generated by the sphingomyelin pathway. These pathways (eg.
sphingosine-1-phosphate) are over-active in tumor cells, and their inhibition
by
phenoxodiol leads to the prevention of production of key pro-survival proteins
such as XIAP. XIAP, an anti-apoptotic protein, prevents cell death by blocking
signals coming from the death receptors on the cell surface. Removal of such
anti-apoptotic proteins restores the ability of tumor cells to undergo apoptosis
in response to chemotherapy.
The
putative primary molecular target of phenoxodiol is a family of proteins
expressed on the surface of tumor cells, but not on non-tumor cells. The
restriction of expression of that family of proteins to tumor cells is thought
to account for the high specificity of phenoxodiol.
Phenoxodiol
is able to kill ovarian cancer cells that are highly resistant to standard
anti-cancer drugs, as well as being able to restore sensitivity in these
cells
to standard anti-cancer drugs such as taxanes. These findings have been borne
out in recent clinical results showing that some women who have stopped
responding to taxane and platinum drugs had disease regression when phenoxodiol
was given in combination with their chemotherapy.
About
Marshall Edwards, Inc.
Marshall
Edwards, Inc. (Nasdaq : MSHL) has licensed rights from Novogen Limited (Nasdaq
:
NVGN) to bring phenoxodiol 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 regulation of the
sphingomyelin pathway. 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 arty
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.