WILEX AG: ARISER Independent Data Monitoring Committee (IDMC) recommends conducting the final analysis of the pivotal Phase III trial with RENCAREX®
Ad-hoc release pursuant to § 15 Wertpapierhandelsgesetz (German Securities Trading Act)
Munich, Germany, 21 November 2011. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today announced that the IDMC has recommended cancelling the interim analysis and performing the final DFS analysis of the Phase III ARISER trial with RENCAREX® in clear cell renal cell carcinoma (ccRCC) now. This decision follows discussions with the Medical Advisory Board, the Food and Drug Administration (FDA) in the USA and the Swedish regulatory authority as well as WILEX’s EU and US commercialisation partners Esteve, S.A., Barcelona, and Prometheus Laboratories Inc., San Diego, CA, USA.
Over the last year the recurrence rate has further declined leading the advisors to conclude that the trial has matured such that the final analysis can be conducted now instead of after 512 events as originally planned. WILEX therefore plans to complete the final analysis immediately following the necessary approvals from the regulatory authorities. In the meantime the trial remains blinded.
The process of formal protocol amendment will start immediately. Upon approval by the regulatory authorities the final analysis will take place and full results may be expected in Q4 2012.
+++ End of the ad-hoc release +++ Further information in the press release.
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the company has a broad portfolio of near-to-market therapeutic and diagnostic products for the targeted treatment and specific detection of various types of cancer. The company’s therapeutic product candidates are based on antibodies and small molecules. Through its US subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of research use only and in vitro diagnostic tests under the brand Oncogene Science®. These diagnostic tests could be developed as companion diagnostics in clinical trials and for therapy monitoring. The wholly owned subsidiary Heidelberg Pharma AG gives WILEX access to an attractive and highly promising antibody drug conjugate technology platform and a pre-clinical service business. The business model of WILEX covers the entire value chain in the oncology market and comprises research, technology, development collaboration as well as sales and marketing. WILEX’s customers and partners include leading international pharmaceutical companies.
Website: http://www.WILEX.com, ISIN DE0006614720 / WKN 661472 / Symbol WL6
Katja Arnold (CIRO)
Manager Investor Relations & Public Relations
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
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