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news.ZymoGenetics has begun treating patients in its open-label, multi-center Phase II safety and efficacy study of interleukin 21 in previously untreated patients with metastatic melanoma. The study is being run by the National Cancer Institute of Canada Clinical Trials Group at Queen's University located in Kingston, Ontario.
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The primary endpoint of the study is the objective tumor response or lack of early disease progression. The trial is expected to enroll approximately 30 patients at a dose of 50mcg/kg. Endogenous interleukin 21 (IL-21) has potent biological activity in regulating key classes of immune cells, including cytotoxic T cells and natural killer cells. These cell types play important roles in eliminating malignant and infected cells.
Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: “There’s a great need for effective treatments for advanced stage melanoma. Our Phase I data suggests that IL-21 could be effective in treating metastatic melanoma. In this Phase II study, we’ll investigate IL-21 treatment further by administering the maximum dose that can be tolerated in the outpatient setting.”