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Human Genome Sciences Reports Positive Data from Long-Term Treatment with LymphoStat-B(R) in Patients with Active Systemic Lupus Erythematosus
Date:11/9/2007

s well tolerated in combination with SLE standard- of-care therapy during long-term exposure, with incidence rates of adverse events, serious adverse events, malignancies, infections and laboratory abnormalities remaining comparable to placebo or decreasing through 2.5 years of treatment (Merrill et al).

"The results through 2.5 years confirm and extend the results reported at Weeks 52 and 76," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "At Week 52 in LymphoStat-B patients with active SLE, we saw significant reductions in SLE disease activity versus placebo as measured by the SELENA SLEDAI and BILAG indices, the Physician's Global Assessment, and, most importantly, by the response rate chosen as the primary efficacy endpoint of the Phase 3 trials. We are encouraged by the continued improvement in these patients, and by the improvement over time in patients crossing over from placebo to LymphoStat-B after 52 weeks. If the Phase 2 results are confirmed in our ongoing Phase 3 trials, we believe that LymphoStat-B could represent a breakthrough in the treatment of SLE."

The primary objectives of the Phase 2 study were to evaluate the efficacy and safety of LymphoStat-B (belimumab) 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. At the end of 52 weeks, 345 patients chose to participate in an optional 24-week extension phase of the study, during which all patients received LymphoStat-B. At Week 76, 296 patients chose to remain on LymphoStat-B treatment in an open-label long-term continuation phase of the Phase 2 trial, in which all patients are receiving 10 mg/kg LymphoStat-B. As of October 1, 2007, 244 patients remained on LymphoStat-B treatment in the continuation stu
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SOURCE Human Genome Sciences, Inc.
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