Rochester, NY 7/14/2009 9:14:32 PM
MSHL - Marshall Edwards, Inc., to Undertake Analysis of Ovature Trial
Marshall Edwards Inc.
Marshall Edwards Inc., MSHL
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Marshall Edwards, Inc., today announced that it will be undertaking an un-blinded analysis of the data from its Phase III international, multicenter clinical study known as "Ovature". Subject to ethical and regulatory approvals, patients currently enrolled in the trial will continue their treatment according to the study protocol. However, new patient recruitment into the Ovature study will cease and the available data from the 141 completed and current patients will be analyzed for safety and efficacy outcomes. As noted by the Independent Data Monitoring Committee in its last review, there have been no significant safety concerns raised to date. Data analysis for the primary endpoint, progression free survival, is expected to be completed within three months. Per the study protocol, the secondary endpoint, overall survival, cannot be analyzed until 18 months after the last patient was randomized, or sooner if there are no patients surviving.
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