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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

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
28.07.2005
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.
end of announcement                               euro adhoc 28.07.2005 07:00:00

Further inquiry note:

Oliver Renner
Head Corporate Business Communication
Tel.: +49 (0)30 468 12431
Fax: +49 (0)30 468 16646
E-Mail: oliver.renner@schering.de

Branche: Pharmaceuticals
ISIN: DE0007172009
WKN: 717200
Börsen: Baden-Württembergische Wertpapierbörse
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Plus de actualités: Schering Deutschland GmbH
Plus de actualités: Schering Deutschland GmbH