Zealand Pharma and Helsinn announce the advance of elsiglutide into Phase II for the prevention of chemotherapy-induced diarrhea in cancer patients

First patients dosed in Phase IIa study of novel GLP-2 peptide agonist

06-Mar-2012 - Denmark

Zealand Pharma A/S and Helsinn announced that the first patients have been dosed in a Phase IIa study of elsiglutide (ZP1846) for the prevention of chemotherapy-induced diarrhea in cancer patients. Elsiglutide is a potent and selective glucagon-like-peptide-2 (GLP-2) agonist invented by Zealand Pharma and licensed to Helsinn.

The Phase IIa study is a randomized, double-blind and placebo-controlled proof-of-concept study to assess the efficacy and safety of elsiglutide for the prevention of chemotherapy-induced diarrhea (CID) in colorectal cancer patients receiving 5-fluorouracil (5-FU)-based chemotherapy. In the study, elsiglutide is administered subcutaneously in parallel with 5-FU. The Phase IIa study is conducted by Helsinn and plans to enroll 138 cancer patients in approximately 20 centers across European countries.

Helsinn is also completing a Phase Ib study of elsiglutide in Europe under an Investigational New Drug (IND) with the US Food and Drug Administration (FDA) so far showing that the drug candidate is safe and well tolerated at doses above the expected therapeutic dose in colorectal cancer patients.

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