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

oan T. Merrill, M.D., F.A.C.R., study investigator, and Program Chair, Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation. "There is a significant need for new and more effective treatments for these patients, and we look forward to having the belimumab Phase 3 results available in 2009."

About the LymphoStat-B (belimumab) Phase 3 Development Program

The belimumab Phase 3 development program includes two double-blind, placebo-controlled, multi-center Phase 3 superiority trials -- BLISS-52 and BLISS-76 -- to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in patients with serologically active SLE. The design of the two trials is similar, but the duration of therapy in the two studies is different -- 52 weeks for BLISS-52 and 76 weeks for BLISS-76. The data from BLISS-76 will be analyzed after 52 weeks in support of a potential Biologics License Application (BLA). HGS designed the belimumab Phase 3 program in collaboration with GSK and leading international SLE experts.

"The belimumab clinical investigators have done a tremendous job in completing the randomization and initial dosing of BLISS-52 and BLISS-76 on our original timeline, despite the size and complexity of these studies," said Ann L. Wang, Vice President, Clinical Operations, HGS. "They have enrolled nearly 1700 patients worldwide into these Phase 3 trials. We are one step closer to results that we hope will confirm belimumab's potential to offer a significant new treatment option for patients with SLE."

The primary efficacy endpoint of BLISS-52 and BLISS-76 is the patient response rate 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
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SOURCE Human Genome Sciences, Inc.
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