Aphton Reports Data From Insegia, Chemotherapy Trial

Aphton has released final data from a double-blind, placebo-controlled Phase III clinical trial of Insegia (G17DT immunogen) in combination with Gemzar (gemcitabine; Lilly) in patients with solid tumors.

The trial was a randomized, double-blind, placebo-controlled study in previously untreated patients with locally advanced, recurrent or metastatic pancreatic cancer. Patients were randomly assigned to receive Insegia plus gemcitabine or gemcitabine plus placebo.

The primary endpoint of this 383-patient study was overall survival. Secondary endpoints included overall tumor response, time to tumor progression and an evaluation of survival by antibody response levels. Results of the study showed no statistically significant difference in overall survival, tumor response or time to tumor progression.

However, in the study approximately 75 percent of patients achieved an antibody response to treatment with Insegia. An evaluation of survival by antibody response showed that patients who achieved the highest levels demonstrated a statistically significant difference in survival relative to the control group. The differences in survival were seen across covariate factors, such as stage of disease and performance status.