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Human Genome Sciences Completes Enrollment in Second Phase 3 LymphoStat-B(R) Trial
Date:8/27/2008

indicate a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which would indicate a moderate flare of disease activity).

In each of the two Phase 3 trials, patients have been randomized to one of three treatment groups: 1 mg/kg belimumab, 10 mg/kg belimumab, or placebo. Patients are dosed intravenously on Days 0, 14 and 28, then every 28 days for the duration of the study. All receive standard of care therapy in addition to the study medication. Safety and tolerability are evaluated by an independent Data Monitoring Committee throughout both studies.

About LymphoStat-B (belimumab)

Belimumab is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS(R). 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 and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies - antibodies that attack and destroy the body's own 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.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately 1.5 million people in the United States and approximately 5 million worldwide suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and America
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SOURCE Human Genome Sciences, Inc.
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