FDAnews
www.fdanews.com/articles/73657-point-therapeutics-initiates-phase-ii-clinical-trial-of-talabostat

POINT THERAPEUTICS INITIATES PHASE II CLINICAL TRIAL OF TALABOSTAT

June 27, 2005

Point Therapeutics has announced that it has initiated a Phase II clinical trial of the company's lead therapeutic compound, Talabostat, for the treatment of metastatic pancreatic cancer.

The study is designed to evaluate the anti-tumor activity of Talabostat in combination with gemcitabine in patients with metastatic pancreatic cancer.

The trial design is a single-arm, two-stage study in up to 60 patients with metastatic pancreatic cancer. The primary clinical endpoint will be six-month survival. Secondary study endpoints include overall survival, progression-free survival, quality of life, and performance status.

According to the American Cancer Society, pancreatic cancer is the fourth leading cause of cancer death in the U.S. In 2005 alone, 32,180 new cases of pancreatic cancer will be diagnosed and 31,800 people will die of the disease.