Heidelberg Pharma AG

Regulatory Filings • Dec 15, 2006

News Details

Ad-hoc | 15 December 2006 17:24

WILEX receives approval for clinical Phase II trial with oral WX-671 in pancreatic cancer

Ad hoc announcement transmitted by DGAP – a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. —————————————————————————— WILEX receives approval for clinical Phase II trial with oral WX-671 in pancreatic cancer Munich, December, 15, 2006 The Munich-based biopharmaceutical company WILEX AG (ISIN DE0006614720 / Frankfurt Stock Exchange / Prime Standard) today received the clinical trial authorisation (CTA) from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) for a clinical Phase II trial with its drug candidate WX-671 in combination with the chemotherapeutic agent Gemcitabine (Gemzar®, Eli Lilly and Company, Indianapolis, USA) in pancreatic cancer patients. WILEX plans to conduct the study in approximately 30 centres with 90 patients in several European countries. The trial is a randomised, open label Phase II-trial in patients with locally advanced, inoperable, non-metastatic pancreatic cancer. Patients are to be treated with oral WX-671 once-a-day in combination with the standard treatment of Gemcitabine (intravenous once weekly). This trial is designed to assess the anti-metastatic activity of the combination therapy and will follow several parameters, including progression free survival and time to first metastases. Patient recruitment is expected to start in Q2 2007 with the first data expected to be available in H1 2008. Contact Juliane Giese Manager Public Relations WILEX AG Grillparzerstr. 16 81675 München Germany Tel.: +49 (0)89-41 31 38-29 Fax: +49 (0)89-41 31 38-99 Email: juliane.giese@wilex.com Website: http://www.wilex.com (c)DGAP 15.12.2006 ————————————————————————— Language: English Issuer: WILEX AG Grillparzerstr. 16 81675 München Deutschland Phone: +49 (0)89 41 31 38 – 0 Fax: +49 (0)89 41 31 38 – 99 E-mail: info@wilex.com WWW: www.wilex.de ISIN: DE0006614720 WKN: 661472 Indices: Listed: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin-Bremen, Düsseldorf, München, Stuttgart End of News DGAP News-Service —————————————————————————