Helsinn Healthcare S.A. and Zealand Pharma A/S announced Wednesday that Helsinn has begun a phase IIB clinical dose finding trial of elsiglutide, which is used to prevent diarrhea caused by chemotherapy.
The first patients from the intended total of 600 colorectal cancer patients being treated with chemotherapy have been given dosages in the phase IIB trial.
“Chemotherapy-induced diarrhea is a debilitating side effect of chemotherapy, which significantly impacts on the ability of patients to benefit from cancer treatment regimens. It is a significant area of unmet need in the treatment of cancer,” Helsinn CEO Riccardo Braglia said.
Many patients who receive chemotherapy, especially 5-fluorouracil to treat colorectal, breast and head and neck cancers, suffer damages to their intestines, which leads to diarrhea. The side effect can cause dehydration, hospitalization, sub-optimal cancer treatment and a reduced quality of life. Phase I and phase IIA of the trial showed encouraging results in the safety and efficacy of elsiglutide’s diarrhea prevention in colorectal patients receiving chemotherapy.
Zealand invented elsiglutide, and Helsinn possesses the license to elsiglutide’s global development and commercial rights for its use in cancer care outside the Nordic countries.
“Helsinn has a world-leading position in cancer supportive care and, if the beneficial effects seen with elsiglutide can be confirmed, it opens important new treatment options for cancer patients of not only relieving a serious side effect but also providing a possible basis for a more effective cancer treatment,” Zealand President and CEO Britt Meebly Jensen said.
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