www.fdanews.com/articles/102440-zymogenetics-begins-melanoma-trial
ZymoGenetics Begins Melanoma Trial
December 19, 2007
ZymoGenetics has started treatment in a Phase II safety and efficacy study of Interleukin 21 (IL-21) in previously untreated patients with metastatic melanoma.
The primary endpoint of the open-label, multicenter 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 50 mcg/kg.
Nicole Onetto, ZymoGenetic’s senior vice president and chief medical officer, said the trial will investigate the maximum dose of IL-21 that can be tolerated in an outpatient setting.