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Ipsen (IPN.PA) Release: "PRIMARYS" Study Investigators Observed Clinically Relevant Results in an Investigational Phase III Study With Somatuline® Autogel® 120 mg in Patients With Acromegaly


6/18/2013 9:53:12 AM

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PARIS--(BUSINESS WIRE)--Ipsen (Euronext: IPN; ADR: IPSEY) today announced the results of an international phase IIIB study, PRIMARYS, assessing an investigational use of Somatuline® Autogel® (lanreotide) 120mg as first line therapy in newly diagnosed acromegaly patients with a macroadenoma. While PRIMARYS did not meet statistical significance with respect to its primary efficacy endpoint, investigators observed clinically relevant tumor volume reductions, in a majority of patients. Data from secondary biomarker endpoints of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels were further supportive of these findings. Baseline GH level was the main factor identified as potential predictor for tumor response to primary therapy. Data were presented at the Endocrine Society1 annual congress (ENDO Congress, San Francisco, USA) on June 16th, 2013.

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