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 June, 2007
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
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
1 June, 2007
ASX
& MEDIA RELEASE
1
JUNE, 2007
PHASE
III TRIAL FOR PHENOXODIOL TO RECRUIT NEARLY 500 PATIENTS WITH RECURRENT OVARIAN
CANCER AT 60 HOSPITALS WORLDWIDE
Novogen
Limited’s subsidiary, Marshall Edwards Inc. (NASDAQ: MSHL), has made the
following announcement:
OVArian
TUmor REsponse (“OVATURE”) trial enrolls first US patient
Dallas,
Texas, May 30 – Researchers at the Harold C. Simmons Comprehensive Cancer Center
at the University of Texas Southwestern Medical Center (UTSMC) have enrolled
the
first US patient in the worldwide clinical trial looking at oral phenoxodiol
in
combination with carboplatin for the treatment of recurring ovarian
cancer.
Phenoxodiol
has been shown in laboratory testing to be successful in restoring sensitivity
of cancer cells from patients with ovarian cancer who have become resistant
to
standard chemotherapy drugs.
At
UTSMC,
the OVATURE trial will be led by John Schorge, MD, Associate Professor of
gynecologic oncology.
"Earlier
clinical studies have shown that phenoxodiol has an excellent safety profile,
with few side effects, and that it appears to re-establish the sensitivity
needed for chemotherapy drugs to work," said Dr Schorge. “We’re
proud to be part of this trial because the advances in ovarian cancer are few
and far between. We hope we can play a leadership role in finding
ways to beat this deadly disease.”
This
Phase III study will recruit 470 patients at approximately 30 centers in the
United States and 30 hospitals throughout Europe and
Australia. Phenoxodiol, a capsule taken by mouth, is an
investigational drug that has not yet been approved by the FDA. In
the OVATURE trial, patients are randomly divided into two groups and receive
either oral phenoxodiol in combination with carboplatin (a standard chemotherapy
drug) or carboplatin with an inactive control capsule. Neither
patient nor doctor will know which group each patient is in.
All
patients will receive carboplatin on a weekly basis, instead of receiving the
customary carboplatin treatment of one intravenous infusion every three weeks,
because some studies have shown that patients whose tumors have become resistant
to the three-week standard regimen of carboplatin may respond to the weekly
administration of the drug. Accordingly, researchers hope that
patients on both arms of the trial may benefit.
“This
is
the first of many prestigious U.S. institutions which will be participating
in
this trial,” said Dr Patti Rossi, Vice President, Clinical Operations,
Marshall Edwards, Inc. “Patients nationwide should have access to
this trial, with as little disruption to their daily lives as
possible. Accordingly, we’re working with institutions across the US
which will be joining the trial shortly.”
About
Chemo-Resistant Ovarian Cancer
In
many
patients with ovarian cancer, cancer cells develop resistance to standard
chemotherapy drugs, known as "chemoresistance," making it difficult to
successfully manage and treat cancer.
According
to the Ovarian Cancer National Alliance:
|
·
|
Ovarian
cancer, the deadliest of the gynecologic cancers, is the fifth leading
cause of cancer death among U.S. women. Ovarian cancer occurs in
1 out of
69 women;
|
|
·
|
About
20,000 women are diagnosed with the disease each
year;
|
|
·
|
About
15,000 women in the United States die from ovarian cancer each
year;
|
|
·
|
Currently,
55 percent of the women diagnosed with ovarian cancer die from it
within
five years; among black women only 40 percent survive five years
or
more.*
|
About
Phenoxodiol
Phenoxodiol
has shown the ability to kill cancer cells that are relatively resistant to
standard chemotherapy drugs in laboratory studies. The ability of
phenoxodiol to overcome chemoresistance is thought to be due to its potential
to
disrupt various resistance mechanisms the cancer cell has
developed.
In
2004,
phenoxodiol received fast track designation by the FDA for refractory ovarian
cancer. Fast track allows for the expedited development of drugs that
are intended to treat serious or life-threatening conditions and that
demonstrate a potential to address unmet medical needs.
About
MEI
Marshall
Edwards Inc. is a leading biotechnology company in the development of cancer
therapies. MEI is currently developing a range of anti-cancer
therapies that represent the next generation of oncology drugs.
Marshall
Edwards Inc. (Nasdaq: MSHL) is 78.1 percent owned by the pharmaceutical company,
Novogen Limited (NASDAQ: NVGN; ASX: NRT), from which it
licenses phenoxodiol. More information on phenoxodiol and on the company can
be
found at www.marshalledwardsinc.com and www.novogen.com
* Sources: U.S.
Cancer Statistics Working Group. United States Cancer Statistics: 2003 Incidence
and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention and National Cancer
Institute; 2006. Available at:
htttp://www.cdc.gov/cancer/npcr/uscs.
Ries
LAG,
Harkins D, Krapcho M, Mariotto
A,
Miller BA,
Feuer EJ, Clegg L, Eisner MP, Horner
MJ, Howlader N, Hayat M, Hankey BF, Edwards BK (eds). SEER Cancer Statistics
Review, 1975-2003, National Cancer Institute. Bethesda,
MD. Available
at: http://seer.cancer.gov/csr/1975_2003/.
Based on November 2005 SEER data
submission, posted to the SEER web site 2006.
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.
#
#
#
Bethesda,
MD. Available
at: http://seer.cancer.gov/csr/1975_2003/.
Based on November 2005 SEER data
submission, posted to the SEER web site 2006.
ISSUED
FOR: NOVOGEN
LIMITED
LISTINGS: ASX
(CODE NRT), NASDAQ (CODE NVGN).
FOR
FURTHER
INFORMATION: CHRISTOPHER
NAUGHTON, MANAGING 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