Point enrolls first patient in second phase 3 trial of lung cancer drug talabostat

By Angela McDaniels

Seattle, Feb. 8 - Point Therapeutics Inc. said it has enrolled the first patient in its second phase 3 clinical trial of talabostat, which will compare a combination of the drug and pemetrexed to pemetrexed with a placebo in patients with metastatic non-small cell lung cancer.

This phase 3 clinical program began in October and includes two randomized, double-blind, placebo-controlled trials with up to 800 patients at roughly 100 sites in North America.

The primary study endpoint is progression-free survival, according a company news release. Secondary endpoints include overall survival, objective response rate, duration of response and quality of life.

"Initiating patient enrollment in our second phase 3 trial is an important milestone for talabostat's development and the company overall," president and chief executive officer Don Kiepert said in the release.

The first phase 3 trial has already enrolled 400 patients and is evaluating the combination of talabostat with docetaxel versus docetaxel and a placebo.

Point predicted it will have trial results for both studies in late 2007.

The company said it decided to pursue the phase 3 program after a phase 2 trial of talabostat with docetaxel in patients with metastatic non-small lung cancer showed a 14.3% response rate.

Of the six responding patients, two experienced complete responses. Of the first 40 patients enrolled in the study, 48% have survived for at least 12 months, according to the release.

Point Therapeutics is a Boston-based biopharmaceutical company that develops dipeptidyl peptidase inhibitors for use in treating cancer and type 2 diabetes and as vaccine adjuvants.

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