PanGenetics' CD40 enters Ph I trial

Dutch drug developer PanGenetics BV has received formal regulatory approval to initiate clinical evaluation of its CD40 antagonist antibody, PG102. The multicenter trial in Hungary and Serbia will recruit patients with active psoriatic arthritis, and is designed as a double-blind, placebo-controlled, single ascending-dose study.

The primary objective of the Phase I program is to evaluate the safety and tolerability of PG102. The design includes evaluation of pharmacodynamic and clinical parameters, to provide further insight into the immuno-modulatory mechanisms of PG102. The trial will commence in the next few weeks and the results, which include an extended follow-up period, are expected in the fourth quarter of 2009.

A precursor of this antibody was previously successfully evaluated in an open label study in Crohn's disease patients. The experience from this earlier work, combined with a comprehensive preclinical package, provided the basis for the clinical trial authorizations.