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 OVArian TUmor REponse (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.
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