FDAnews
www.fdanews.com/articles/72465-point-therapeutics-presents-positive-results-in-talabostat-nsclc-study

Point Therapeutics Presents Positive Results in Talabostat NSCLC Study

May 18, 2005

Point Therapeutics has presented positive results in the company's Phase II study of talabostat in combination with docetaxel in patients with advanced non-small cell lung cancer (NSCLC).

The company announced that 36 evaluable patients have completed the 18-week treatment period. These patients had all previously failed first-line treatment for NSCLC. To date, five patients have demonstrated a clinical response to treatment. Two patients had a complete response, defined as a complete disappearance of their tumor. In addition, three patients had a partial response - one with a 92 percent decrease in lesion size, one with a 66 percent decrease in lesion size and one with a 52 percent decrease from maximum disease burden.

These results led to an overall response rate of 13.9 percent. In addition, results on the secondary endpoint of progression-free survival (PFS) were also positive with a median PFS of four months compared to the historically reported median of 2.9 months for docetaxel alone. At this time, median survival cannot be calculated because of a lack of deaths in the study.