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News Breaks
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November 23, 2009
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| 08:04 EDT |  | CEPH |
| theflyonthewall.com: | Cephalon Phase IIb/III Cinquil trial does not meet endpoint | | Ception Therapeutics and Cephalon announced results from a Phase IIb/III clinical trial for CINQUIL as a treatment for pediatric eosinophilic esophagitis. The study was designed to evaluate improvement in the co-primary endpoints of changes in esophageal eosinophil levels and clinical symptoms. Analyses of the data indicated that patients treated with CINQUIL showed a statistically significant reduction in esophageal eosinophil levels versus placebo. In the second co-primary endpoint, patients treated with CINQUIL showed an improvement in their clinical symptoms; however, placebo treated patients also experienced an unexpectedly large improvement in their symptoms. Therefore, the study did not achieve statistical significance for this endpoint. CINQUIL was well tolerated in the study, with an adverse event profile comparable to placebo Ception and Cephalon continue to fully analyze the data and are planning to perform an analysis of an ongoing open-label extension study to help further assess the clinical results. :theflyonthewall.com |
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