Human Genome Sciences Completes Enrollment in First of Two Phase 3 Lymphostat-B...(at Week 52 as defined by: A reduction fr...),Health

Date:4/22/2008

at Week 52, as defined by: A reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale; no worsening of disease as measured by the Physician's Global Assessment (worsening defined as an increase of more than 0.30 points from baseline); no new BILAG A organ domain score (which would 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 are 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 study medication. Safety and tolerability are evaluated by an independent Data Monitoring Committee throughout both studies.

About LymphoStat-B

LymphoStat-B (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 infections. 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. Pre-clinical and clinical studies demonstrate that B-cell antagonists can reduce autoantibody levels and help control autoimmune disease activity.

About the Collaboration with GSK

In August 2006, HGS and GSK entered into a co-development and commercialization agreement under which HGS has responsibility for conducting the LymphoStat-B Phase 3 trials, with assistance
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SOURCE Human Genome Sciences, Inc. Copyright©2008 PR Newswire. All rights reserved

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