Independent Data Monitoring Committee Reviews Marshall Edwards, Inc.'s Arrangements for Data Analysis of the Ovature Trial
June 17 2009 - 8:30AM
Marketwired
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 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: Professor Alan Husband 011 612 9878-0088 (Australia)
Email Contact Warren Lancaster +1-203-966-2556 (USA) Email
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