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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 randomis
Ed, double-masked, placebo-controlled stud
Y of the
Ab in the t
Reatment 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.
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.
Gevokizumab (XOMA 052/S 78989) is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory diseases and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine that has been shown to be involved in Behçet's and other forms of non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases. In binding to IL-1 beta, gevokizumab inhibits the activation of the IL-1 receptor, thereby modulating the cellular signaling events that produce inflammation.