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Ipsen SA Announces Positive Results from CLARINET Phase III Clinical Trial of Somatuline


Saturday, 28 Sep 2013 10:30am EDT 

Ipsen SA announced that CLARINET study met its primary endpoint by demonstrating that Somatuline statistically significantly prolonged time to disease progression or death in non-functioning GEP-NET patients (p=0.0002; hazard ratio 0.47; 95% CI: 0.30–0.73). After two years of treatment with Somatuline, disease progression or death was reduced by 53%: 62% of GEP-NET patients treated with Somatuline had not progressed or died versus 22% with placebo. The pre-specified subgroup analyses showed that the antiproliferative effect of Somatuline is statistically significant in midgut tumors, clinically relevant in pancreatic NETs and independent of the tumor grade and hepatic tumor load. The safety data generated from the study are consistent with known safety profile of Somatuline. 

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