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 October, 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
23 October, 2007
ASX
& MEDIA RELEASE
23
OCTOBER, 2007
YALE CANCER CENTER
SPONSORS STUDY OF PHENOXODIOL FOR PROSTATE CANCER
Novogen
Limited’s subsidiary, Marshall Edwards Inc. (NASDAQ: MSHL), has made the
following announcement:
Researchers
seek to build on previous study indicating investigational drug phenoxodiol
prolonged time to progression and PSA doubling time
(New
Haven, Conn., October 22) Yale researchers have begun recruiting 60
men for a clinical trial investigating an experimental new drug, oral
phenoxodiol, as a potential first line therapy for prostate
cancer. The study is funded by Yale Cancer Center
.
The
clinical trial will be conducted at two sites, Yale Cancer Center and
the West Haven (Conn.) Veterans Administration Hospital. Yale Cancer
Center, a National Cancer Institute designated comprehensive cancer center
for
over 30 years, is one of only 39 Centers in the nation and the only
comprehensive center in Southern New England.
“Promising
data on phenoxodiol in prostate cancer piqued our interest,” said Wm. Kevin
Kelly, D.O., principle investigator for the trial, Associate Professor of
Medicine and Associate Director of Clinical Investigations, Yale Cancer
Center. “This trial builds on the success of the previous prostate
cancer trial with phenoxodiol. We will compare results from two types
of prostate cancer patients – those with androgen independent disease and those
with androgen dependent disease.”
“If
successful, development of phenoxodiol has the potential to provide a
significant advancement in the treatment of prostate cancer,” said Dr.
Kelly.
About
the Study
All
patients in the trial will receive 400 mg of oral phenoxodiol every 8 hours
daily for 28 consecutive days (1 cycle). Treatment outcome will be
evaluated after three cycles (12 weeks) of drug
administration. Patients with progression of disease will be taken
off study. Responding and stable disease patients will remain on study until
disease progression or for a maximum of 12 cycles (approximately 12
months).
The
primary endpoint of the trial is to determine the proportion of patients given
phenoxodiol that have a 50 percent post-therapy prostate specific antigen (PSA)
decline at 12 weeks in patients with:
|
a)
|
Androgen
independent disease who are chemotherapy naïve (Group A);
and
|
|
b)
|
Rising
PSA after radical prostatectomy or radiotherapy that are androgen
dependent (Group B)
|
The
study
will also evaluate safety of phenoxodiol in these patient populations. PSA
is a
protein produced by the cells of the prostate gland. PSA is present in small
quantities in the serum of normal men, and is often elevated in the presence
of
prostate cancer and in other prostate disorders.
Selection
Criteria
The
study
is open to prostate cancer patients of any race and ethnicity who are at least
18 years of age. All patents have to show evidence of disease progression and
have adequate hematologic, renal and hepatic function. Patients must
not have had surgery in the 4 weeks prior to the trial.
A
total
of 60 eligible patients will be enrolled. The study calls for enrolling 25
eligible subjects into Group A and 35 eligible subjects into Group
B.
A
study
coordinator will help patients interested in the trial to learn if they are
eligible, as other selection criteria apply. Interested patients
should contact Elin Rowen, RN, Yale Cancer Center, (203) 737-2445,
elin.rowen@yale.edu.
Earlier
Study Indicates Phenoxodiol Delays Disease Progression
A
Phase
II clinical research study demonstrated a dose dependent anti-tumor effect
by
phenoxodiol in men with hormone refractory prostate cancer. The trial
was designed to end after 24 weeks of treatment, but was extended to 90 weeks
because of the unexpected prolongation of time to progression in some
patients. No phenoxodiol-associated toxicities were reported in the
study.
Researchers
administered oral phenoxodiol to 26 patients at one of four dose levels, two
subtherapeutic levels (20 mg and 80 mg three times daily) and two therapeutic
levels (200 mg and 400 mg three times daily). Response to therapy was
determined on the basis of PSA response, PSA doubling time, and time to
progression.
While
all
12 patients on the two lower dose levels of phenoxodiol showed disease
progression within 6 months, nine (9) of the 14 patients on the
higher doses of phenoxodiol remained progression-free on phenoxodiol after
6
months, indicating that disease progression occurred far more frequently in
the
lower subtherapeutic dose treatment group. In terms of PSA levels,
the 12 patients in the two lower dose groups saw no improvement, while 3 of
the
14 patients in the higher dose groups experienced a PSA level reduction of
50
percent or greater from baseline. The PSA doubling time increased
from a mean of 18 weeks to 43 weeks, not including the 3 of 14 patients who
remained on phenoxodiol beyond the term of the study.
This
study was lead by Robert Davis, MD,
Sir Charles Gairdner Hospital, Perth, Australia, and was
presented at the AACR-NCI-EORTC International Conference on Molecular Targets
and Cancer Therapeutics, Philadelphia, November 17, 2005.
About
Prostate Cancer
According
to the National Cancer Institute, prostate cancer is the second most common
type
of cancer among men in this country and the second leading cause of cancer
death
among men in the U.S.1 Only lung cancer
is more common and kills more men. Prostate cancer will be diagnosed
in more than 230,000 men in 2006, and approximately 28,000 men will die of
the
disease.2 At least forty
percent of all men diagnosed with prostate cancer will at some point experience
recurrent disease after definitive local therapy with radiation or
prostatectomy. Most commonly, recurrence is manifested as a rising
PSA and/or the development of metastatic disease.3
Treatment
options for early stage prostate cancer in androgen dependent pre-metastatic
disease are limited. Patient options typically include “watchful
waiting” or anti-androgen treatment, a form of chemical castration that is
particularly unattractive for men who at this stage of disease are otherwise
healthy.
About
phenoxodiol
Phenoxodiol
is being developed by Marshall Edwards, Inc. as a therapy for late-stage,
chemoresistant ovarian cancer and for prostate and cervical
cancers. It 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 induces cell death by apoptosis and restores the
sensitivity of chemoresistant tumor cells to other chemotherapy
drugs. The putative molecular target for phenoxodiol is a
cancer-specific protein, accounting for the highly selective nature of the
drug.
This
helps explain the findings that phenoxodiol has been shown not to adversely
affect normal cells in animal and laboratory testing.
Phenoxodiol
has received Fast Track status from the FDA to facilitate development as a
therapy for recurrent ovarian and prostate cancers. Phenoxodiol is an
investigational drug and, as such, is not commercially available. Under U.S.
law, a new drug cannot be marketed until it has been investigated in clinical
trials and approved by FDA as being safe and effective for the intended
use.
Phase
III Multinational Trial for Ovarian Cancer Patients
Underway
Phenoxodiol
in combination with carboplatin is currently being studied
in a multi-national Phase III clinical trial called the
OVATURE (OVArian TUmor
REsponse) Trial, following positive findings of previous trials
conducted in Australia and at Yale-New Haven Hospital. The OVATURE
trial is taking place at up to 60 clinical sites in the United States, Europe,
and Australia. Preliminary results from the trial are expected within
18 months. For more information on the trial, visit
www.OVATUREtrial.com.
About
Marshall Edwards, Inc.
Marshall
Edwards, Inc. (NASDAQ: MSHL) is majority owned by Novogen (NASDAQ: NVGN), 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
http://www.marshalledwardsinc.com and
http://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.