Schering Deutschland GmbH

euro adhoc: Schering AG
Planned interim analysis of CONFIRM 2 trial of PTK/ZK indicates low probability of demonstrating overall survival benefit in second-line therapy of metastatic colorectal cancer

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Schering AG announced today the disclosure data from the CONFIRM 2 trial with PTK/ZK in the second-line treatment of metastatic colorectal cancer (mCRC). This decision was based on information obtained after trading hours on July 27, 2005 and included a review by the independent Data Safety Monitoring Board (DSMB) showing a low probability of demonstrating an improvement in overall survival at final analysis. The DSMB assessment was based on a planned interim analysis.

Progression free survival (PFS), a secondary endpoint of the study, was improved in favor of the PTK/ZK treatment arm with greater effect observed in the pre-defined patient sub-group with high Lactate dehydrogenase (LDH) levels consistent with findings previously seen in CONFIRM 1.

In light of these findings the regulatory filing strategy and timelines will be reviewed.

Further results of CONFIRM 2 are expected in mid-2006.

The decision to disclose the CONFIRM 2 data does not impact the other ongoing Phase III trial, CONFIRM 1, which will continue as planned with final overall survival results expected in the second half of 2006.

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ots Originaltext: Schering Deutschland GmbH
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Further inquiry note:
Oliver Renner
Head Corporate Business Communication
Tel.:  +49 (0)30 468 12431
Fax: +49 (0)30 468 16646

Branche: Pharmaceuticals
ISIN:      DE0007172009
WKN:        717200
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