XOMA Shares Quiet Following Results of Two Phase 2 Trials Showing Gevokizumab Program 'Very Encouraging,' 'Compelling'

XOMA Corporation XOMA, a leader in the discovery and development of therapeutic antibodies, today announced very encouraging results from two Phase 2 clinical studies that are part of the Company's broad gevokizumab proof-of-concept ("POC") program. Erosive Osteoarthritis of the Hand Phase 2 POC Study The Phase 2 POC study in erosive osteoarthritis of the hand ("EOA") patients with elevated C-reactive protein ("CRP") levels greater than or equal to 2.5 mg/L is a double-blind, placebo-controlled study to determine if gevokizumab can improve the pain, stiffness, and physical function associated with EOA after three and six months of treatment, based upon the Australian/Canadian Osteoarthritis Hand Index ("AUSCAN™") scoring scale. AUSCAN is a validated self-administered questionnaire specifically designed to assess the three dimensions of pain, disability, and joint stiffness of osteoarthritis of the hand using a series of 15 questions. XOMA's study enrolled 85 EOA patients who were randomized 2:1 to receive 60 mg of gevokizumab or placebo, dosed subcutaneously once monthly. In this study, the percent change in AUSCAN score is measured from baseline on a monthly basis, with efficacy assessments calculated at Day 84 and Day 168. The Day 84 results demonstrate gevokizumab-treated patients experienced a greater lowering in their mean AUSCAN score than patients in the placebo-treated group. After three months of treatment, patients who received gevokizumab (n=57) demonstrated a 23 percent reduction from baseline in the composite AUSCAN score compared to a 14 percent reduction in placebo arm patients (n=28). In addition to AUSCAN score, Day 84 and Day 168 endpoints also include radiographic images to assess the potential change in joint damage from baseline. The study will continue on a blinded basis until all patients receive the full six months of treatment. Upon completion of the study, including the analysis of radiographic images of the affected joints, and the conclusion of the supplemental study in patients with CRP less than 2.5 mg/L, both of which are expected to occur in the first quarter of 2014, XOMA will determine the requirements for a potential Phase 3 program based on advisory and regulatory input.