Biotech Values

[DonShimoda]

XOMA Initiates Safety and Efficacy Study of Gevokizumab in Patients With Non-Infectious Uveitis Currently Controlled by Systemic Treatment

BERKELEY, Calif., Oct. 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 believe that 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 doses of gevokizumab or placebo, 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.

XOMA Will Host a Conference Call at 4:30 p.m. Eastern Time Today to Discuss the Global Phase 3 Gevokizumab Program http://bit.ly/WuSk3P