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Independent Data Monitoring Committee Reviews Marshall Edwards, Inc.'s Arrangements for Data Analysis of the Ovature Trial
| Source: Marshall Edwards, Inc.
NEW CANAAN, CT--(Marketwire - June 17, 2009) - The Independent Data Monitoring Committee
(IDMC) created to oversee the conduct of the Phase III OVArian TUmor
REsponse (OVATURE) Trial, which convened during the recent Annual Meeting
of the American Society of Clinical Oncology, considered the data
accumulated to date and reviewed the arrangements announced by the Company
for early termination of patient enrollment into the study.
The IDMC reviewed available unblinded data from 117 subjects and noted
that, at the time of termination of recruitment, 142 subjects had been
randomized to the study.
The IDMC supported the Company's decision to close the study to accrual,
and, in a review of the available safety data, the IDMC confirmed that
there were no safety concerns with phenoxodiol in these subjects.
Consistent with the IDMC charter, the Company will convene an expert
committee to review the IDMC recommendations including those with respect
to the disposition of subjects remaining in the OVATURE study.
The IDMC recommended that the final analyses be completed as soon as
possible. A full review of the outstanding tasks now indicates that
completion of data collection and database lock will likely require a
further six months for analysis of the primary efficacy endpoint of
Progression Free Survival. At that stage, a number of pre-specified subset
analyses will also be performed.
The IDMC was advised that, since the tasks to achieve full study completion
and database lock were now clearly defined, the previous Clinical Services
Agreement has been terminated and a new contract is being established for
the final stages of data collection and site close-out. This is being
offered by way of tender to a number of Contract Research Organizations, to
ensure the study is completed as quickly and as efficiently as possible.
The OVATURE trial is a major multi-center international Phase III clinical
trial of orally-administered investigational drug 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 recruited ovarian cancer patients whose cancer initially
responded to chemotherapy, but had since become resistant or refractory to
traditional platinum treatments. The trial was approved by the U.S. Food
and Drug Administration (FDA) under a Special Protocol Assessment (SPA)
program, and the protocol provided for an analysis of interim results after
95 of the planned 340 recruited patients experienced disease progression.
It is anticipated that analyses after the early termination of recruitment
following randomization of 142 patients will yield results from a greater
number of progressed patients than was required for the planned interim
analysis.
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 is believed to have 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 over-expressed 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, inducing cancer cell death via caspase expression
and promoting sensitivity to other chemotherapeutics. 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 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.
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 (ASX : NRT ) (NASDAQ : NVGN ) to bring three oncology drugs --
phenoxodiol, triphendiol and NV-143 -- to market globally. 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. 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
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
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from our dependence upon, collaboration or contractual arrangements
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