GlobeImmune begins phase II trial in pancreas cancer

The primary goal of the study is to compare the recurrence-free survival at 15 months in patients treated with either GI-4000 or placebo, in combination with adjuvant gemcitabine after surgery.

Pancreas cancer is an aggressive, deadly disease; median overall survival for patients with early-stage disease is typically 13-20 months.

GI-4000 is a tarmogen (targeted molecular immunogen), designed to stimulate “killer” T cells in the immune system to find and destroy diseased cells.

“Despite successful surgery, pancreas cancer remains a lethal disease. Among patients who have had surgery, 50% die from recurrent tumors within two years and only 20% are alive at five years. These patients are in serious need of effective new treatments,” said Dr David Apelian, chief medical officer of GlobeImmune. “We are pleased to have initiated a phase II study that explores the potential of tarmogens in such a critical area.”

GI-4000 is designed to activate the immune system against cancer cells containing a mutated protein called Ras that is found in 80-90% of pancreas tumors. In a recently completed phase I study of end-stage pancreas and colorectal cancer patients, GI-4000 was generally well-tolerated across the full range of doses tested. Immune responses to GI-4000 were observed in many patients despite the advanced stage of cancer studied in this trial.