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Zealand Pharma A/S and Helsinn Announce Positive Results of Phase IIa Clinical Study for Prevention of Chemotherapy-Induced Diarrhea


Tuesday, 28 May 2013 05:16am EDT 

Zealand Pharma A/S and its partner, the Swiss pharmaceutical group Helsinn, jointly announce that Helsinn has concluded a Phase IIa study with elsiglutide for the prevention of chemotherapy-induced diarrhea in cancer patients, with positive results. Elsiglutide is a potent and selective glucagon-like-peptide-2 (GLP-2) receptor agonist invented by Zealand and licensed to Helsinn for the development and use in cancer supportive care. In a randomized, double-blind, placebo-controlled Proof-of-Concept Phase IIa clinical study, Helsinn has assessed the efficacy and safety of elsiglutide for the prevention of chemotherapy-induced diarrhea. The study was conducted under an open Initial New Drug (IND) application with the U.S. Food and Drug Agency in 19 European centers and enrolled 138 colorectal cancer patients. The patients were treated with 5-fluorouracil (5-FU) based chemotherapy. Concurrently, Helsinn has completed a Phase Ib study, showing that elsiglutide is safe and tolerated at doses well above expectable therapeutic level. Based on the results from the proof-of-concept study, Helsinn is now planning a Phase IIb study to further evaluate the efficacy of elsiglutide. Study activities are expected to start in H2 2013.