SYDNEY, AUSTRALIA and LONDON and NEW CANAAN, CT 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 an investigational
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 meeting, held at the Royal College of Obstetricians and
Gynaecologists, attracted more than 200 internationally located
scientists and clinicians specializing in ovarian cancer. It was
organized to provide a forum for scientific advances in fundamental
biology, diagnosis and treatment of ovarian cancer. A principal
focus of the meeting was to gain a clearer understanding of the
role of existing and new therapies in ovarian cancer clinical
practice.
In a session of the conference devoted to The Challenge of Drug
Resistance, Professor Alan Husband, Group Director of Research for
Marshall Edwards, Inc., was invited to present the most recent
findings from both basic and clinical research exploring the
potential for the investigational drug phenoxodiol to contribute to
the treatment and management of advanced ovarian cancer.
Professor Husband said in his presentation: "Options for
treating ovarian cancer in patients who are resistant to currently
available drugs remains an important area of unmet clinical need.
The vast majority of patients who respond initially to platinum and
taxane drugs will at some stage become resistant or refractory to
their effects."
"Phenoxodiol is a first in class drug, producing anti-cancer
effects via targeting a surface oxidase" Professor Husband said.
"The promising chemosensitizing effects seen in Phase II studies of
phenoxodiol are now being evaluated in combination with a novel
platinum therapeutic regimen in a Phase III registration trial, the
OVATURE study. "
"The promising efficacy, coupled with the favorable safety and
low side effect profile of phenoxodiol seen in previous studies,
suggests that this investigational 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."
The OVArian TUmor REponse (OVATURE) trial is a major
multi-center multinational Phase III clinical trial of
orally-administered phenoxodiol in combination with carboplatin 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. More information on the
trial can be found at http://www.OVATUREtrial.com.
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 are receiving weekly carboplatin and phenoxodiol.
Patients in the other trial arm are also receiving weekly
carboplatin, but a placebo (an inactive control pill) is
substituted for phenoxodiol. Neither patients nor their doctors
know to which trial arm the patients are randomly assigned.
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). 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 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 patient
recruitment to this study is completed and 95 patients have disease
progression.
Patients are being recruited at hospital sites across USA, UK,
Europe and Australia. The trial design has been approved by the
U.S. Food and Drug Administration (FDA) under a Special Protocol
Assessment (SPA) program, and provides for an interim analysis of
the data, which, if statistically significant, can be used to
support a request for accelerated marketing approval.
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 cancer cell survival and
responsible for the development of drug resistance.
In cancer cells, phenoxodiol appears to selectively inhibit the
pro-survival regulator known as S-1-P (sphingosine-1-phosphate)
that is overexpressed 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 its
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 (ASX: NRT) (NASDAQ: NVGN) to bring three oncology
drugs -- phenoxodiol, triphendiol 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;106(2):354-61.
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.
Contacts: David Sheon 202 518-6321 Email Contact Chris Naughton
011 61 2 9878 0088 Email Contact
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