XOMA Finalizes Plans for Gevokizumab Phase 3 Clinical Program in Pyoderma Gangrenosum

XOMA Corporation

, a leader in the discovery and development of therapeutic antibodies, announced today that based on its meeting with the U.S Food and Drug Administration (FDA), the Company is finalizing its plans for a gevokizumab Phase 3 program in pyoderma gangrenosum (PG), a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers. During the meeting, the Company and the FDA reviewed the data generated from XOMA's pilot trial in six PG patients. The pilot study was designed to determine if gevokizumab, an IL-1 beta modulating antibody, should be explored in pivotal studies in patients with active PG. XOMA is incorporating the FDA's verbal and written responses regarding the clinical design of the studies into a final Phase 3 program, which it will submit to the Agency for any final comments. The Phase 3 program is expected to include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll approximately 60 patients with active PG. The primary endpoint is complete wound closure of the target ulcer at approximately four months. XOMA anticipates conducting these parallel studies in the United States and several other countries. "The interest we have received from the medical community and the patients who suffer from pyoderma gangrenosum ulcerations reflect their desire to have access to therapeutic options that have been studied specifically in and are approved for this under-served patient population. We were very pleased the FDA agreed PG is a serious rare condition that has been identified as an unmet medical need with no approved therapies and that the input we received has allowed us to design a Phase 3 program we believe we can successfully execute in our targeted PG population," stated Paul Rubin, Senior Vice President, Research and Development and Chief Medical Officer of XOMA. "While we await final comments on our protocol, we are actively engaged in site identification and pre-study start-up activities to ensure their investigators and clinical staff are prepared to enroll eligible patients as quickly as possible once we launch the studies." Gevokizumab has been granted Orphan Drug Designation by the FDA for the treatment of PG. About Gevokizumab Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and has the potential to treat patients with a wide variety of inflammatory diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine, and modulates the cellular signaling events that produce inflammation. IL-1 beta has been shown to be involved in diverse array of disease states, including non-infectious uveitis (including Behçet's uveitis), cardiovascular disease, and other auto-inflammatory diseases. Gevokizumab currently is being studied in a global Phase 3 clinical program, termed EYEGUARD™, which is being conducted by SERVIER and XOMA. This program is designed to determine gevokizumab's ability to treat acute non-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye in EYEGUARD-A, to prevent disease flares in patients with Behçet's uveitis in EYEGUARD-B, and to prevent disease flares in NIU patients who are controlled with steroids in EYEGUARD-C. XOMA has a Proof-of-Concept (POC) program underway in which the Company is exploring the efficacy and safety of gevokizumab in multiple indications. Separately, SERVIER initiated a Phase 2 study to determine gevokizumab's ability to reduce arterial wall inflammation in patients with marked atherosclerotic plaque inflammation and who have experienced an acute coronary syndrome event in the previous twelve months, as well as POC studies in polymyositis/dermatomyositis, giant cell arteritis, and Schnitzler syndrome. Information about gevokizumab clinical studies can be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu.