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Extended Accrual Time and Decreased Sample Size for OVATURE, a Multinational Phase III Clinical Study for Women With Recurrent Ovarian Cancer
| Source: Marshall Edwards, Inc.
SYDNEY, AUSTRALIA and LONDON and NEW CANAAN, CT--(Marketwire - May 9, 2008) - The accrual
time for the OVArian TUmor REsponse (OVATURE) clinical study, a Phase III
study of the investigational chemosensitizing drug, phenoxodiol, has been
extended to facilitate complete patient enrollment in the U.S., Europe, and
Australia. Increasing the accrual period allowed decreasing the total
number of patients in the study, without changing the required statistical
analyses. As a result, the OVATURE study will enroll 340 patients at 60 to
80 clinical sites throughout the United States, Europe, and Australia.
Initially, this study was announced to enroll 470 patients.
The primary outcome of the OVATURE trial is the assessment of the relative
time it takes for the ovarian cancer to progress. The OVATURE trial design
has been approved by the US 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. An analysis of
interim results will be possible after patient recruitment to this study is
completed and 95 patients have disease progression.
Phenoxodiol is being developed by the U.S. 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 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 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. 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.
Patients are being recruited at clinical sites across USA, UK, Europe and
Australia. Currently, more than 25 sites in the U.S., 20 sites in
Europe/UK, and five sites in Australia are participating in this clinical
study.
Patients and caregivers who are interested in learning more about the
OVATURE trial should visit a website for this study at
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 cell membrane 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 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, with a consequent decrease in expression of the pro-survival
proteins XIAP and FLIP, rendering those cells more sensitive to
chemotherapy. Indeed, in laboratory studies, it has been demonstrated that
drug-resistant ovarian 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 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.
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 in the cell membrane
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,
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.
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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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
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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
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