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news.Danish biotechnology company Zealand Pharma and partner, the Swiss pharma group Helsinn have jointly announced that Helsinn’s Phase IIa study with elsiglutide for the prevention of chemotherapy-induced diarrhea in cancer patients has been completed with positive results.
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Invented by Zealand and licensed to Helsinn, elsiglutide is a potent and selective glucagon-like-peptide-2 (GLP-2) receptor agonist and is developed for use in cancer supportive care.
Helsinn evaluated the efficacy and safety of elsiglutide in a randomized, double-blind, placebo-controlled Proof-of-Concept Phase IIa clinical study, which treated patients with 5-fluorouracil (5-FU) based chemotherapy.
Zealand president and CEO David Solomon said that Diarrhea is a common ailment and in many cases severe complication of chemotherapy, resulting in reduced quality of life, dehydration, hospitalization and in some cases non-optimal cancer treatment.
He added that the findings of the Proof-of-Concept study would support the potential of the Zealand invented peptide drug candidate as a novel preventative therapy that may offer cancer patients relief from chemotherapy induced diarrhea.
With 138 colorectal cancer patients enrolled in 19 European centers, the study was carried out under an open Initial New Drug (IND) application with the US Food and Drug Agency.
During the Phase Ib study, elsiglutide was shown to be safe and tolerated at doses higher than expectable therapeutic level.
The company now plans to launch a Phase IIb study to further evaluate the efficacy of elsiglutide to prevent chemotherapy induced diarrhea in cancer patients.