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www.fdanews.com/articles/68814-trial-of-insegia-in-pancreatic-cancer-does-not-meet-primary-endpoint

Trial of Insegia in Pancreatic Cancer Does Not Meet Primary Endpoint

February 16, 2005

Aphton has announced that its Phase III study of Insegia in combination with chemotherapy did not meet its primary efficacy endpoint of improving overall survival in patients with pancreatic cancer.

Insegia (G17DT immunogen) is an investigational therapeutic immunotherapy directed at the growth hormone gastrin. This study randomized 383 previously untreated patients with metastatic pancreatic cancer, to receive Insegia plus gemcitabine (Gemzar, Eli Lilly) versus gemcitabine alone.

The adverse event profile in this study showed no significant differences between study arms and was similar to the observed events in previous clinical trials.