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XOMA Initiates Safety and Efficacy Study of Gevokizumab in PatientXOMA Initiates Safety and Efficacy Study of Gevokizumab in Patients with Non-infectious Uveitis Currently Controlled by Systemic Treatments with Non-infectious Uveitis03/10/2012
BERKELEY, Calif., October 3, 2012 (GLOBE NEWSWIRE) - XOMA Corporation (Nasdaq: XOMA) today announced it has opened enrollment in a Phase 3 clinical trial, titled A randomizEd, double-masked, placebo-controlled study of the safetY and Efficacy of GevokizUmAb in the tReatment of subjects with non-infectious intermeDiate, posterior or pan-uveitis currently controlled with systemic treatment (EYEGUARD™-C), to determine gevokizumab's potential to reduce the risk of recurrent uveitic disease in patients with non-infectious uveitis intermediate, posterior, or pan-uveitis (NIU). The Company intends to enroll patients with NIU who have experienced active uveitic disease but whose disease currently is controlled with oral corticosteroids with or without immunosuppressive medications.
“Patients often arrive at a physicians’ office with active NIU disease that requires immediate treatment to control symptoms. After the active disease is treated, both the patient and the physician want to maintain the disease in a quiet state over the long term. Today, physicians have to resort to high-dose corticosteroids and immunosuppressives to aid them, yet both carry long-term health consequences. With this new study design, we will be able to determine if gevokizumab can allow physicians to reduce the corticosteroid treatment currently used to maintain the uveitis in a controlled state,” stated John Varian, Chief Executive Officer of XOMA. “While we could have chosen to conduct a standard supplemental safety-only study, we decided to expand our study to an efficacy and safety study for an incremental investment of $5 million, as we believe the investment has significant value creating opportunities for XOMA. Our International Phase 3 study in active NIU, now named EYEGUARD™-A, which started in June, is designed to evaluate the use of gevokizumab for the treatment of active disease, and this trial, EYEGUARD-C gives us the opportunity to potentially aid in the prevention of future exacerbations in patients receiving treatment with less desirable options.”
EYEGUARD-C is designed to enroll 300 patients worldwide. They will be randomized to receive either one of two doses of gevokizumab or placebo dosed monthly for twelve months. All patients will undergo a predetermined reduction in their steroid doses. The study's primary endpoint is the proportion of patients with an occurrence of uveitic disease through Day 168. The study also will assess other important measures of improvement in their uveitic disease including the reduction of steroid use.
Paul Rubin, M.D., XOMA's Senior Vice President of Research and Development and Chief Medical Officer, stated, "It was a natural decision to expand the required safety study to a full efficacy trial, particularly in the NIU patient population. Long-term treatment with corticosteroids is detrimental to the patient’s overall health, and the immunosuppressants being used today put the patient at significant risk of infection. We believe our antibody may be able to prevent acute exacerbation of the disease and allow physicians to reduce or even eliminate the use of corticosteroids and other immunosuppressant medications.”
SERVIER (Suresnes, France), XOMA’s partner jointly developing Gevokizumab and holding rights outside the U.S. and Japan for the NIU indication, hails this additional entry into phase 3 for Gevokizumab. “NIU is a very debilitating disease with no therapeutic options beside potentially harmful long-term corticotherapies. Servier is very delighted by this important step in the clinical development of Gevokizumab, which may ultimately prove its clinical value in inflammatory diseases,” said Isabelle Tupinon-Mathieu, M.D., Head of Therapeutic Research and Development at Servier.
Gevokizumab (XOMA 052) 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.
Servier is XOMA's development and commercialization partner for gevokizumab. XOMA holds rights to gevokizumab in the U.S. and Japan for non-cardiometabolic indications, including non-infectious uveitis, acne, and erosive osteoarthritis of the hand for which clinical studies are ongoing. Information on all gevokizumab clinical studies can be found at www.clinicaltrials.gov.
Gevokizumab has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.
About Non-infectious Uveitis
The term uveitis broadly refers to the inflammatory diseases that affect the portion of the eye known as the uvea, which is the middle of three layers that surround the eye. People with uveitis may experience decreased vision, pain, light sensitivity, and floaters. Uveitis may be caused by an infection that is commonly treated with an antimicrobial agent, or by an unknown pathogen triggering inflammation, called non-infectious uveitis.
The most common form of uveitis affects the front of the uvea and is known as anterior uveitis. Other forms include intermediate uveitis, posterior uveitis, and pan uveitis. These types differ in that they all include involvement of the back portions of the uvea. Posterior uveitis refers to inflammation in the retina and the choroid, and it may result from a different immune response trigger. Pan-uveitis refers to inflammation of all three major parts of the eye. Behçet's uveitis is a well-known form of pan-uveitis. Due to the swelling of tissues critical to vision, intermediate, posterior, and pan-uveitis (which collectively make up NIU) can lead to blindness if not treated.