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news.PanGenetics, a clinical development company, has received formal regulatory approval to initiate clinical evaluation of the company's CD40 antagonist antibody, PG102. The multi-center 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.
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The primary objective of the Phase I study is to evaluate the safety and tolerability of PG102. The study design includes evaluation of pharmacodynamic and clinical parameters, to provide further insight into the immunomodulatory mechanisms of PG102. The study will commence in the next few weeks and the results of the study, which includes an extended follow-up period, are expected in the fourth quarter of 2009.
PG102 is a functional antagonist of human CD40 and has a unique mechanism of action in that it down-regulates signaling without interfering with the binding of CD40 ligand to CD40.
Kevin Johnson, CEO of PanGenetics, said: “For any small company, initiating a clinical study is a significant milestone, and in this instance underscores our ability as a clinical development organization in a challenging and evolving regulatory environment.”