ROCKVILLE, Maryland November 9, 2007 Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the presentation of Phase 2 clinical results demonstrating that LymphoStat-B (belimumab) achieved a sustained improvement in disease activity across multiple clinical measures, decreased the frequency of disease flares over time, and was well tolerated through 2.5 years on treatment in combination with standard of care in patients with active systemic lupus erythematosus (SLE). The results will be the subject of an oral presentation today in Boston at the Annual Scientific Meeting of the American College of Rheumatology (ACR).
SLE is a chronic disease, and patients need new therapies that provide durable efficacy with a favorable safety profile, said Michelle A. Petri, M.D., M.P.H., Professor, Division of Rheumatology, Department of Medicine, Johns Hopkins University. The Phase 2 results presented at ACR showed that the significant clinical benefit observed for LymphoStat-B in serologically active SLE patients at 52 weeks appears to be sustained through 2.5 years. We look forward to further evaluation of LymphoStat-B in larger Phase 3 studies, which are ongoing.
A separate poster presentation of the safety profile of LymphoStat-B showed that LymphoStat-B was 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 Physicians Global Assessment,
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