NEW CANAAN, CT -- (Marketwire) -- 06/17/09 -- 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.
