Biotech Values

[DonShimoda]

XOMA Announces Servier Has Initiated Phase 3 Gevokizumab Trial in Patients With Behcet's Uveitis

BERKELEY, Calif., Sept. 27, 2012 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA) today announced its partner, Servier has received authorization to initiate the Servier-sponsored Behçet's uveitis Phase 3 clinical trial in several European countries. The study is titled A randomisEd, double-masked, placebo-controlled studY of the Efficacy of GevokizUmAb in the tReatment of patients with Behçet's Disease uveitis (EYEGUARD™-B). The objective of this study is to evaluate the efficacy of gevokizumab as compared to placebo on top of current standard of care (immunosuppressive therapy and oral corticosteroids) in reducing the risk of Behçet's disease uveitis exacerbations and to assess the safety of gevokizumab.
"Behçet's uveitis patients now have the opportunity to participate in the gevokizumab Phase 3 clinical trial designed specifically for their unique condition," stated John Varian, Chief Executive Officer of XOMA. "Servier's commitment to this underserved market merits recognition, and we continue to be impressed by their team's passion to design the best trial to determine gevokizumab's efficacy in treating this disease."
"Servier is committed to developing innovative treatments for diseases with clear unmet medical needs, such as Behçet's disease. In addition, we strongly believe gevokizumab has a real potential in other inflammatory diseases," said Emmanuel Canet, MD, PhD, President R&D Servier.

The global EYEGUARD-B study is designed to enroll 110 patients with a history of Behçet's disease uveitis with ocular involvement of the posterior segment who have experienced a recent ocular exacerbation that was treated successfully with high doses of corticosteroids. Patients will be randomized to either a 60mg dose of gevokizumab or placebo administered subcutaneously every four weeks on top of their current immunosuppressive and corticosteroid therapies. The study's primary endpoint is the time to first acute ocular exacerbation, which will be measured once a predefined number of exacerbations have been observed.