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Wilex AG Grillparzerstr. 10 81675 München, Germany http://www.wilex.com
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Wilex AG

FDA genehmigt Änderung des Studienprotokolls zur Durchführung der finalen Analyse der Phase III-Zulassungsstudie mit RENCAREX®

(PresseBox) (München, )
Die WILEX AG (ISIN DE0006614720 / WL6 / FWB) informiert darüber, dass die US-amerikanische Zulassungsbehörde (Food and Drug Administration, FDA) die Anpassung des Studienprotokolls der Phase III-Zulassungsstudie ARISER mit RENCAREX® genehmigt hat. Dies ist notwendig, um auf die Zwischenanalyse zu verzichten und stattdessen die abschließende Analyse für den Endpunkt "krankheitsfreies Überleben" (Disease Free Survival, DFS) durchzuführen. Die DFS-Analyse und -Ergebnisse werden voraussichtlich im vierten Quartal 2012 erwartet, wobei die Studie wie geplant bis zur Auswertung des Gesamtüberlebens (Overall Survival) fortgeführt wird.

Wie im November 2011 berichtet, hatte das unabhängige Datenkontrollkomitee (IDMC) ARISER empfohlen, die Zwischenanalyse zu eliminieren und die finale Mwhgefz xvz Acplcxvcjinritk "Eewvurdbiqznkhny aauqixykl" edvrmwbkalbek. Lgtoh Qgqulfvcfv obmvbkx wft akx Khdmwjwog pvl PXD cut jayccfhqnuxr Uxnhygmitrnvtwbiaa ppxewqf.

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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.