Schering Deutschland GmbH

euro adhoc: Schering AG
PTK/ZK CONFIRM 1 Phase III Study Shows Positive Drug Effects in Metastatic Colorectal Cancer - Filing Now Anticipated for Early 2007

--------------------------------------------------------------------- Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement. --------------------------------------------------------------------- 21.03.2005 Schering AG announced today that the analysis of progression free survival (PFS) as assessed by central radiology review in the CONFIRM 1 trial with the investigational drug PTK/ZK based on information obtained after trading hours on March 18, 2005 did not achieve statistical significance. However, a separate pre-planned analysis of progression-free survival as assessed by the investigators achieved statistical significance. Further analysis of the data including more detailed evaluations of subpopulations are ongoing to fully assess the potential benefit of PTK/ZK. Based on a review of the CONFIRM 1 results, an independent data monitoring board recommended the phase III clinical trial program to continue to allow analysis of overall survival endpoints. This is expected in the second half of 2006. Another ongoing phase III trial, CONFIRM 2, compares the PTK/ZK combination regimen to FOLFOX-4 alone in patients with metastatic colorectal cancer who have progressed after irinotecan-based chemotherapy. An interim analysis is planned in mid 2005 and final overall survival data are expected in mid 2006. Filing for approval with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) is now anticipated in early 2007. end of announcement euro adhoc 21.03.2005 05:30:00 --------------------------------------------------------------------- Further inquiry note: Oliver Renner Head Corporate Business Communication Tel.: +49 (0)30 468 12431 Fax: +49 (0)30 468 16646 E-Mail: Branche: Pharmaceuticals ISIN: DE0007172009 WKN: 717200 Index: DAX, Prime Standard, CDAX, HDAX, Prime All Share Börsen: Baden-Württembergische Wertpapierbörse / regulated dealing SWX Swiss Exchange / regulated dealing Niedersächsische Börse zu Hannover / regulated dealing New York / ADR Berliner Wertpapierbörse / official dealing Hamburger Wertpapierbörse / official dealing Frankfurter Wertpapierbörse / official dealing Börse Düsseldorf / official dealing Bayerische Börse / official dealing Bremer Wertpapierbörse (BWB) / official dealing

Das könnte Sie auch interessieren: