Jul 1 2010
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that it has reached the enrollment goal of 325 patients for its Phase 2b dose-ranging clinical trial of XOMA 052, and that it expects patient enrollment to close in July 2010, with top-line results available in the first quarter of 2011. XOMA 052 is a therapeutic antibody candidate that inhibits the pro-inflammatory cytokine interleukin-1 beta (IL-1 beta) which drives the inflammatory cause of Type 2 diabetes.
The Phase 2b trial, in which Type 2 diabetes patients are randomized to receive one of four dose levels of XOMA 052 or placebo administered monthly over six months, is designed with the primary endpoint of mean change in glycosylated hemoglobin (HbA1c) levels compared to baseline. Secondary endpoints include additional diabetes parameters as well as measures of inflammatory and cardiovascular disease. Prior to enrolling, patients were on a stable regimen of metformin monotherapy for at least 12 weeks before treatment with XOMA 052 or placebo.
"Achieving the enrollment goal for our Phase 2b clinical trial is a significant milestone in the development of XOMA 052 to treat Type 2 diabetes," said Steven B. Engle, Chairman and Chief Executive Officer of XOMA.