HGS TO LAUNCH TWO TIRALS OF LUPUS TREATMENT

Human Genome Sciences (HGS) announced the start of its Phase III clinical development program for LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus. The company plans to submit the final LymphoStat-B Phase III protocols to FDA soon for a Special Protocol Assessment.

The development program will include two double-blind, placebo-controlled, multicenter superiority trials that will evaluate the efficacy and safety of LymphoStat-B plus standard of care, versus placebo plus standard of care.

LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator (BLyS). BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies -- antibodies that attack and destroy healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrate that B-cell antagonists can reduce autoantibody levels and help control autoimmune disease activity.