German biotechnology firm MediGene has initiated a clinical Phase IIa trial of its drug candidate RhuDex for the treatment of rheumatoid arthritis. The first patient has already received treatment in this placebo-controlled study, which is designed to evaluate the compound's tolerability and determine the appropriate dosage for a Phase II evaluation. The Phase IIa results are expected in the last half of 2007. Upon completion of this evaluation, which will include 35 patients, a Phase II trial with more than 200 patients is scheduled, starting in 2008.
RhuDex is a novel, orally-available T cell co-stimulation modulator. According to Medigene, by specifically blocking T-cell activation it reduces the release of inflammatory cytokines involved in this autoimmune disease.
Peter Heinrich, the firm's chief executive, said he believes RhuDex has significant potential for the treatment of rheumatoid arthritis as not only does it intervene at the early stage of the disease process but is also orally available.
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