Avant's TP10 delayed on protocol changes

Avant Immunotherapeutics says that, after discussions with the US Foodand Drug Administration, it is making protocol changes to the Phase IIb trials of its lead complement inhibitor, TP10, in approximately 40-70 infants undergoing cardiac surgery using cardiopulmonary bypass. The company has agreed to monitor patients for six months following treatment, as well as the previously-planned 60-day follow-up.

These protocol changes will result in longer clinical trials, with completion of the Phase IIb study now expected in first-half 2002. Initiation of the pivotal Phase III trial in this high-risk population would start following meetings with the FDA after the end of the Phase IIb studies. Avant's vice president for medical affairs, Alistair Wheeler, said the "ongoing Phase II study of TP10 in adults undergoing cardiac surgery remains on track, and these protocol changes only affect the pediatric trials."