Press Releases
Interim Three Month Data From Ongoing Six Month XOMA 052 Phase 2a Trial Support Safety And Biological Activity
BERKELEY, Calif., Jan. 6, 2011 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced that it has conducted an interim review of three-month data from a Phase 2a clinical trial of XOMA 052 in a small group of 74 patients with Type 2 diabetes focused on evaluating safety where XOMA 052 was shown to be well-tolerated, the primary goal of the study. This Phase 2a trial was designed as an exploratory trial focused on overall safety and kinetics and was not designed to show statistically significant differences in measures of biological activity. XOMA 052 is being studied in an ongoing 420 patient, six month Phase 2b dose-ranging clinical trial where results are expected by the end of this quarter and the primary goal of the study is reduction in levels of hemoglobin A1c. The primary goal of the Phase 2a trial was to gain additional XOMA 052 safety information in Type 2 diabetes patients on a background of stable metformin monotherapy. In this study, XOMA 052 was well tolerated with no significant differences in adverse events, lab abnormalities and vital signs between XOMA 052 and placebo and no drug-related adverse events. At the time of this three month interim review, evidence of biological activity was observed, including a reduction in C-reactive protein levels and a modest reduction in hemoglobin A1c levels. XOMA 052 is designed to inhibit the pro-inflammatory cytokine interleukin-1 beta that is believed to be a primary trigger of pathologic inflammation in Type 2 diabetes. XOMA is jointly developing XOMA 052 in collaboration with Servier. "The interim data from this ongoing trial in a small group of patients treated over three months continue to support the hypothesis that reducing inflammation through IL-1 inhibition is a safe approach to treating diabetic patients," said Marc Y. Donath, M.D., Professor and Chief, Department of Endocrinology, Diabetes and Metabolism at University Hospital Basel, Switzerland, a pioneer in the therapeutic use of IL-1 inhibition in patients with Type 2 diabetes and principal investigator in the landmark study reported in the New England Journal of Medicine in 2007.
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