Human Genome Sciences Completes Enrollment in First of Two Phase 3 Lymphostat-B... (jects. The results of previous studi...)

Human Genome Sciences Completes Enrollment in First of Two Phase 3 Lymphostat-B(R) Trials

Date:4/22/2008

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"The results of previous studies suggest that belimumab significantly reduced SLE disease activity in serologically active patients," said Professor Sandra V. Navarra, M.D., a principal investigator and head of Rheumatology at the University of Santo Tomas, Manila, Philippines. "There is a great need for better tolerated and more effective treatments for lupus, and we look forward to seeing the first Phase 3 data for belimumab by mid-2009."

About the LymphoStat-B Phase 3 Development Program

The LymphoStat-B 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 LymphoStat-B 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 LymphoStat-B Phase 3 program in collaboration with GSK and leading international SLE experts.

"A total of nearly 1700 patients worldwide will be enrolled and randomized in the Phase 3 trials of belimumab, making this the largest double-blinded clinical development program ever undertaken in lupus patients," said William W. Freimuth, M.D., Ph.D., Vice President, Clinical Research - Immunology, Rheumatology and Infectious Diseases, HGS. "Today's milestone brings us closer to seeing Phase 3 data that we hope will confirm belimumab's promise as a potential treatment for patients with SLE. We are grateful for the superb performance of our clinical investigators, whose diligence made it possible to complete the enrollment of BLISS-52 ahead of our fall 2008 projection."

The primary efficacy endpoint of BLISS-52 and BLISS-76 is the patient response rate
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Human Genome Sciences Completes Enrollment in First of Two Phase 3 Lymphostat-B...(jects. The results of previous studi...),Health