Rochester, NY 8/5/2009 7:51:56 PM
Pre-Market - Marshall Edwards,Inc., MSHL - Marshall Edwards, Inc. To Undertake Intensive Analysis Of Ovature Trial
Marshall Edwards,Inc.
Marshall Edwards, Inc. announced that it will be undertaking an un-blinded analysis of the data from the company’s Phase III international, multicenter clinical study known as Ovature (OVArian TUmor REsponse). Subject to ethical and regulatory approvals, patients currently enrolled in the trial will continue their treatment according to the study protocol.
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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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