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Human Genome Sciences Reports That a Phase 2 Study of LymphoStat-B,Showed Significant Reductions in Disease Activity in Patients with,Active Systemic Lupus Erythematosus

d, double-blind, placebo-controlled Phase 2 trial, 96% (351/364) elected to enter the 24-week open-label extension phase of the trial, and 92% (321/351) of those who entered completed it. Of those completing the extension phase, 78% (250/321) continue to receive LymphoStat-B in a long-term continuation study. The trial began in October 2003.

"We are encouraged that nearly all of the patients who completed the 52- week Phase 2 study chose to continue treatment in the 24-week extension phase," said William W. Freimuth, M.D., Ph.D., Vice President, Clinical Research -- Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences. "Many of these patients began treatment more than three years ago and continue on treatment today. This provides us with a substantial body of data on the long-term effects of LymphoStat-B."

About the Phase 2 Trial Results

The primary objectives of the Phase 2 study were to evaluate the safety, tolerability and efficacy of LymphoStat-B plus standard of care, versus placebo plus standard of care. A total of 449 patients with active SLE were randomized to receive one of three different doses of LymphoStat-B or placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy. In the extension phase, all placebo patients received LymphoStat-B at a dose of 10 mg/kg, while patients in the LymphoStat-B 10 mg/kg treatment arm continued on the 10 mg/kg dose, and patients in the 1 mg/kg and 4 mg/kg LymphoStat-B treatment arms were offered the choice of continuing on the same dose or receiving LymphoStat-B at a dose of 10 mg/kg.

In June 2006, HGS reported the 52-week data from the Phase 2 trial of LymphoStat-B in patients with SLE. The 52-week results demonstrated that LymphoStat-B significantly reduced disease activity versus placebo in patients with serologically active SLE, exhibited clinically relevant biological activity, and appeared safe and well t
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