Contact Information: Contacts: David Sheon 202 518-6321 Chris Naughton 011 61 2 9878 0088
European Symposium on Phenoxodiol as an Investigational Drug for Ovarian Cancer Management
Worldwide Pivotal Phase III Study in Women With Recurrent Ovarian Cancer Underway in USA, Europe and Australia
| Source: Marshall Edwards, Inc.
SYDNEY, AUSTRALIA and BERLIN and NEW CANAAN, CT--(Marketwire - October 22, 2007) - A symposium
on platinum resistant ovarian cancer will be held at the European Society
for Gynecological Oncology in Berlin on Sunday, 28 October. Leading cancer
researchers will speak at the symposium which will focus on advances in
platinum therapies and the potential for phenoxodiol as a promising new
investigational drug to restore platinum sensitivity in platinum resistant
ovarian cancer.
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 will be 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.
Speakers at the symposium, will include Prof. Gabra as well as 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.).
A major multinational study, the OVArian TUmor REponse (OVATURE) Trial, is
now underway in over 60 centers around the world. This 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. Preliminary results from the trial are expected within
18 months. For more information on the trial, visit www.OVATUREtrial.com.
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
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