FDA halts talabostat trials on efficacy concerns

Massachusetts, USA-based biopharmaceutical company Point Therapeutics says that the Food and Drug Administration has placed a hold on trials of the oncology agent talabostat, on the advice of an independent data monitoring committee. Interim analysis suggested that the drug had fallen short of primary and secondary efficacy endpoints in two trials examining it, in combination with Sanofi-Aventis' Taxotere (docetaxal), in the treatment of patients with non-small cell lung cancer.

The analysis indicated that patients in the treatment arm had a lower overall survival rate than those in the placebo group. Company president Don Kiepert said that he was surprised and disappointed by the results, but added that it was focusing on the best interests of the patients in the trial and on communicating developments to the relevant regulatory authorities.