POINT THERAPEUTICS CANCER STUDY FAILS MAIN GOAL

Point Therapeutics provided an update on its clinical program, which includes two Phase III trials in Stage IIIb/IV non-small cell lung cancer (NSCLC) and a Phase II trial in Stage IV pancreatic cancer that did not meet its primary endpoint.

In early January, the company provided preliminary results from its open-label Phase II trial of talabostat plus gemcitabine (Gemzarin) in patients with Stage IV pancreatic cancer who had not received prior chemotherapy. The primary clinical endpoint for this study is six-month survival, and secondary study endpoints include overall survival, progression-free survival, quality of life and performance status. Previously, the company reported that 10 of 21 patients evaluable for six-month survival had survived more than six months and that three of 31 patients evaluable for tumor response had demonstrated a clinical response to treatment, including one complete response in a patient with metastatic disease to the liver.

The company recently completed enrollment in the study and has since determined that it will not meet the primary endpoint of six-month survival. Of note, to date, an additional patient has demonstrated a partial clinical response to treatment. The company said it would continue to monitor patients for tumor response, as well as other secondary endpoints. Point said it expects final results to be completed in mid 2007.

Point's NSCLC program consists of two randomized, placebo-controlled, double-blind Phase III studies in the second-line and third-line setting. The first Phase III study evaluates talabostat and pemetrexed (Alimta) versus placebo and pemetrexed. The second study evaluates talabostat and docetaxel (Taxotere) versus placebo and docetaxel. Each study was intended to enroll approximately 400 patients, with an estimated 200 patients per treatment arm. Enrollment in the talabostat/pemetrexed study is on schedule with full enrollment expected in the second quarter of 2007 and results projected in the fourth quarter of 2007. In the talabostat/docetaxel study, enrollment is currently behind the company's original schedule.