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 October, 2007
ASX
& MEDIA RELEASE
29
OCTOBER, 2007
EUROPEAN
SYMPOSIUM FOCUSES ON PHENOXODIOL AS AN INVESTIGATIONAL DRUG FOR OVARIAN CANCER
MANAGEMENT
Novogen
Limited’s subsidiary, Marshall Edwards Inc. (NASDAQ: MSHL), has made the
following announcement:
Worldwide
pivotal phase III study in women with recurrent ovarian cancer underway in
USA,
Europe and Australia
SYDNEY,
AUSTRALIA; BERLIN and NEW CANAAN, CT--(Marketwire - October 29, 2007)
-
A
symposium on platinum resistant ovarian cancer held at the European Society
for
Gynecological Oncology in Berlin on Sunday, 28 October has confirmed the need
for an effective chemosensitizing drug to support new platinum treatment
regimens in resistant ovarian cancer. Leading cancer researchers speaking
at the symposium described advances in platinum therapies and expressed
enthusiasm for phenoxodiol as a promising new investigational drug as part
of a
new approach for this indication.
Phenoxodiol
is being developed by the US oncology company Marshall Edwards, Inc. (NASDAQ:
MSHL
) as a novel therapeutic in combination with carboplatin for
late-stage chemoresistant ovarian cancers, as well as a monotherapy for prostate
and cervical cancers. Phenoxodiol is a novel-acting drug that inhibits key
pro-survival signaling pathways operating within cancer cells causing selective
cancer cell death and increased susceptibility to drugs like platinum and
taxane, to which most ovarian cancer patients become resistant in late stage
disease.
The
Berlin symposium was chaired by Professor Hani Gabra of the Ovarian Cancer
Action Research Centre, Imperial College London, UK, and Professor Ignace
Vergote, of the Catholic University of Leuven, Belgium. Medical
professionals interested in viewing the archived symposium can watch it at
http://www.ovaturetrial.com/esgosymposium
.
Speaking
at the symposium, Prof. Gabra said: "There are a number of interesting
developments in platinum dosing schedules which may assist in improving tumour
responses in resistant women, but the clinical efficacy of these will be
enhanced by improved chemosensitization strategies."
"Already
phenoxodiol has shown promise in improved platinum responses in Phase II
studies. A major multinational Phase III study, the OVATURE Trial, is now
underway in over 60 centers around the world, and we are excited to be part
of
this study," Prof. Gabra said.
The
OVA
rian
TU
mor
RE
ponse
(OVATURE) Trial is a major multi-center multinational Phase III clinical trial
of phenoxodiol in women with advanced ovarian cancer resistant or refractory
to
platinum-based drugs, to determine its safety and effectiveness when used in
combination with carboplatin.
Other
speakers at the symposium included Professor Maria van der Burg
(Erasmus University, Dijkzigt Hospital, Rotterdam, Netherlands),
Professor David Bowtell (Peter MacCallum Cancer Centre, Melbourne, Australia)
and Professor Alan Husband (Director of Research for Marshall Edwards,
Inc.).
Professor
Bowtell reported on the functional significance of genes involved in platinum
resistance, and Professor van der Burg presented new data on the benefits of
weekly platinum dosing. A change from receiving platinum in the
traditional dose pattern (every two to three weeks) to a weekly dosing regimen
has been reported to provide a tumor response in some patients with recurrent
ovarian cancer(1-3). This frequent dosing strategy has been incorporated
into the Phase III OVATURE Trial. Thus, in addition to learning more about
the
safety and efficacy of phenoxodiol, researchers will learn more about the
efficacy and safety of weekly carboplatin.
The
OVATURE Trial is recruiting ovarian cancer patients whose cancer initially
responded to chemotherapy, but has since become resistant or refractory to
traditional platinum treatments. The trial consists of two double blind
treatment arms. Patients in one trial arm will receive weekly carboplatin
and phenoxodiol. Patients in the other trial arm will also receive weekly
carboplatin, but a placebo will be substituted for phenoxodiol. Neither
patients nor their doctors will know to which trial arm the patients are
randomized.
The
primary outcome of the trial is the assessment of the relative time it takes
for
the ovarian cancer to progress. An analysis of interim results will be possible
after 95 patients have disease progression.
Patients
will be recruited into 28 sites in the UK and Europe, 31 sites in the USA,
and 4
sites in Australia. The total number of patients to be enrolled in this pivotal
study is 470.
The
trial
design has been approved by the US Food and Drug Administration (FDA) as a
Special Protocol Assessment (SPA), and provides for an interim analysis of
the
data, which if statistically significant can be used to support a request for
marketing approval.
Professor
Alan Husband said in his presentation at the symposium: "It is gratifying to
hear from the research presented here today that there is new hope for those
ovarian cancer patients who no longer respond to common chemotherapeutic
drugs."
"We
are
keen to see whether the promising chemosensitizing effects seen in Phase II
studies of phenoxodiol are reflected in the OVATURE trial when it is used in
combination with a novel platinum therapeutic regimen," Professor Husband
said.
"The
efficacy, coupled with the high safety and low side effect profile of
phenoxodiol seen in previous studies, suggests that this new drug has the
potential to offer improved therapeutic outcomes in ovarian cancer as well
as
other cancer targets, such as prostate and cervical cancers."
About
phenoxodiol:
Phenoxodiol
is being developed as a chemosensitizing agent, in combination with platinum
drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for
prostate and cervical cancers. It has a unique mechanism of action,
binding to cancer cells via a surface oxidase, causing major downstream
disturbances in expression of proteins necessary for their survival and
responsible for the development of drug resistance.
Phenoxodiol
appears to selectively inhibit the pro-survival regulator in cancer cells known
as S-1-P (sphingosine-1-phosphate) that is over expressed in cancer cells.
In
response to phenoxodiol, the S-1-P content in cancer cells is decreased
rendering those cells more sensitive to chemotherapy. Indeed, in laboratory
studies, it has been demonstrated that cancer cells pre-treated with phenoxodiol
were killed with lower doses of chemotherapy drugs.
Importantly,
phenoxodiol has been shown not to adversely affect normal cells in animal and
laboratory testing.
Phenoxodiol
is being investigated as a therapy for late-stage, chemoresistant ovarian,
prostate and cervical cancers. Phenoxodiol has received Fast Track status from
the FDA to facilitate development as a therapy for recurrent ovarian and
prostrate 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.
Phenoxodiol
is the first of a family of compounds in the Marshall Edwards, Inc.' drug
pipeline of flavanoid derivatives.
About
Marshall Edwards, Inc:
Marshall
Edwards, Inc. (NASDAQ:
MSHL
) is a specialist oncology company focused on
the clinical development of novel anti-cancer therapeutics. These derive
from a flavonoid technology platform, which has generated a number of novel
compounds characterized by broad ranging activity against a range of cancer
cell
types with few side effects. The combination of anti-tumor cell activity
and low toxicity is believed to be a result of the ability of these compounds
to
target an enzyme present on the surface of cancer cells, thereby inhibiting
the
production of pro-survival proteins within the cell. Marshall Edwards,
Inc. has licensed rights from Novogen Limited (NASDAQ:
NVGN
) to bring
three oncology drugs -- phenoxodiol, NV-196 and NV-143 -- to market globally.
The Company's lead investigational drug, phenoxodiol, is in a Phase III
multinational multi-centered clinical trial for patients with recurrent ovarian
cancer. More information on the trial can be found at
http://www.OVATUREtrial.com
.
Marshall
Edwards, Inc. is majority owned by Novogen, 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
www.marshalledwardsinc.com
and
www.novogen.com
.
References
(1)
Piura
B and Meirovitz M. Weekly single-agent carboplatin in heavily pretreated
patients with recurrent ovarian, peritoneal and fallopian tube carcinoma. Eur
J
Gynaecol Oncol. 2005;26(4):386-90.
(2)
Van
der Burg ME, van der Gaast A, Vergote I, Burger CW, van Doorn HC, de Wit R,
Stoter G, Verweij J. What is the role of dose-dense therapy? Int J Gynecol
Cancer. 2005 Nov-Dec;15 Suppl 3:233-240.
(3)
CaDron I, Leunen K, Amant F, Van Grop T, Neven P, Vergote I. The "Leuven" dose
dense paclitaxel/carboplatin regimen in patients with recurrent ovarian cancer.
Gynecol Oncol 2007, in press.
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
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