Aeterna Zentaris Inc. announced that the independent Data Safety Monitoring Board for the Phase 3 X-PECT study of perifosine in patients with refractory advanced colorectal cancer has completed a specified interim analysis for safety and futility. The DSMB recommended that the Phase 3 trial to completion as planned.
The trial is being conducted under a Special Protocol Assessment with the Food and Drug Administration and fast-track status. Moreover, the company has positive Scientific Advice from the European Medicines Agency received for this ongoing Phase 3 trial, which is expected, therefore, sufficient for registration in Europe. Perifosine rights and Yakult Honsha for Japan and licensed to Handok Korea.. Bishop Auckland Magistrates’ Court sentenced W & M Thompson Ltd 3,000 and ordered to pay 1,756 costs? Mr. Armstrong was to a fine? a fine? 200 and ordered? 500 cost.
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