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 May, 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):
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
16 May, 2006
ASX
& MEDIA RELEASE
16
MAY, 2006
Novogen
Limited’s subsidiary, Marshall Edwards Inc. (NASDAQ: MSHL), has just made the
following announcement:
MARSHALL
EDWARDS ACHIEVES SPECIAL PROTOCOL ASSESSMENT AND AGREEMENT WITH FDA ON PHASE
III
(OVATURE STUDY) OF PHENOXODIOL AS A CHEMOSENSITIZING AGENT IN WOMEN WITH
PLATINUM-RESISTANT OVARIAN CANCER
(Washington,
D.C. and Sydney, Australia - 16 May, 2006) Biotechnology company, Marshall
Edwards, Inc., announced today that under the Special Protocol Assessment (SPA)
process, it has reached agreement with the United States Food and Drug
Administration (FDA) on the design of a pivotal study protocol for its
investigational anti-cancer drug, phenoxodiol. The trial, known as the OVATURE
study, is designed to test the ability of phenoxodiol to restore sensitivity
of
late-stage ovarian cancers to carboplatin, a standard form of therapy for
ovarian cancer.
The
SPA
process allows for FDA evaluation of a clinical trial protocol that will form
the basis of an efficacy claim for a marketing application, and provides a
binding agreement that the study design, including patient numbers, clinical
endpoints, and analyses are acceptable to the FDA.
Phenoxodiol
received fast track designation for platinum-resistant or refractory ovarian
cancer from the FDA in 2004 based on Phase II data, and is eligible for FDA’s
programs that are designed to facilitate drug development and expedite marketing
approval of drugs intended to treat serious or life-threatening disease and
to
address unmet medical need. As a fast track product, phenoxodiol will be
eligible for accelerated approval and priority review of the marketing
application.
“We
are
pleased that the FDA has completed the SPA review process and that we have
a
mutually-agreed design that provides us with a clearly defined regulatory
pathway for pursuing marketing approval of phenoxodiol,” said Professor Graham
Kelly, Chairman, Marshall Edwards, Inc.
About
Ovarian Cancer Treatment
Platinum-based
drugs such as cisplatin and carboplatin are a standard form of chemotherapy
in
ovarian cancer, with a high initial response rate. However, at least 85-90%
of
these patients will experience disease recurrence, subsequently showing a lower
level of response to both platinums and other chemotherapies. Most of these
tumors ultimately become resistant to platinums, and platinum-resistant tumors
invariably are resistant to other forms of chemotherapy.
About
OVATURE
Four
hundred and seventy (470) patients are to be enrolled and randomized to two
treatment arms -
(i)
carboplatin + phenoxodiol, and (ii) carboplatin + placebo. The carboplatin
will
be administered weekly intravenously, and the phenoxodiol or placebo will be
capsules administered 8-hourly on a continuous daily basis.
The
trial
will involve up to 60 sites in the United States, the United Kingdom, Europe,
and Australia.
The
primary endpoint of the trial is progression-free survival, representing death
or disease progression, whichever comes first. Overall survival is a secondary
endpoint.
Enrollment
is not expected to open for at least a month. More information about the study
will be available in due course at www.phenoxodiol.com
or
www.clinicaltrials.gov.
These
sites will contain information on when and where the trial is open for
enrollment.
About
PHENOXODIOL
Phenoxodiol
is an investigational drug and, as such, is not commercially available.
Phenoxodiol
is a novel-acting drug that inhibits key pro-survival signaling 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. Loss of activity of these proteins restores the ability of chemo-resistant
tumor cells to undergo apoptosis in response to chemotherapy. The putative
molecular target for phenoxodiol is a tumor-specific protein, accounting for
the
highly selective nature of the drug.
About
Marshall Edwards, Inc.
Marshall
Edwards, Inc. (Nasdaq : MSHL) has licensed rights from Novogen Limited (Nasdaq
:
NVGN) to bring three oncology drugs - phenoxodiol, NV-196 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 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.
ISSUED
FOR : NOVOGEN
LIMITED
LISTINGS : ASX
(CODE NRT),
NASDAQ (CODE NVGN).
FOR
FURTHER
INFORMATION : PROFESSOR
ALAN
HUSBAND, RESEARCH DIRECTOR, NOVOGEN LIMITED
TEL
(02) 9878 0088 http://www.novogen.com
ISSUED
BY : WESTBROOK
COMMUNICATIONS
CONTACT
: DAVID REID TEL (02)
9231 0922 OR 0417 217 157