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| HUMAN GENOME SCIENCES REPORTS POSITIVE LONG-TERM DATA FOR LYMPHOSTAT-B IN PATIENTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | |
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- Phase 2 data demonstrate sustained improvement in disease activity through three years of LymphoStat-B (belimumab) therapy - - No increase in adverse events, malignancies, infections or laboratory abnormalities over time - ROCKVILLE, Maryland – June 12, 2008 – Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the presentation of results from a long-term Phase 2 continuation trial showing that LymphoStat-B® (belimumab) was associated with sustained improvement in disease activity across multiple clinical measures, decreased frequency of disease flares, potential steroid-sparing activity, and was generally well tolerated through three years on treatment in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The results are the subject of a number of oral and poster presentations today in Paris at the 2008 Congress of the European League Against Rheumatism (EULAR). “Based on the results presented at EULAR 2008, the clinical benefit observed for belimumab at Week 52 of this Phase 2 study appears to be durable through three years,” said Richard Furie, M.D., Chief, Division of Rheumatology and Allergy-Clinical Immunology, North Shore Long Island Jewish Health System, Lake Success, NY, and Professor of Medicine, Albert Einstein College of Medicine. “We observe that patients who crossed over from placebo to belimumab after Week 52 have also shown improvement across multiple clinical measures. The durability of clinical effect and the favorable safety profile observed for belimumab suggest that it has the potential to play an important role in the treatment of SLE.” SLE is a chronic, life-threatening autoimmune disease. It is estimated that approximately 1.5 million people in the United States and approximately 5 million worldwide suffer from various forms of lupus, including SLE. “At Week 52 in belimumab patients with serologically active SLE, we saw significant reductions in SLE disease activity versus placebo based on multiple measures of clinical effect, including the response rate chosen as the primary efficacy endpoint of the Phase 3 trials,” said William W. Freimuth, M.D., Ph.D., Vice President, Clinical Research – Immunology, Rheumatology and Infectious Diseases. “We are encouraged by the continued improvement in these patients through three years. Belimumab could represent a significant advance in the treatment of SLE if Phase 2 results are confirmed in the Phase 3 trials that are currently ongoing.” LymphoStat-B (belimumab) is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in August 2006. The first Phase 3 data for LymphoStat-B are expected by mid-2009, and all Phase 3 data to support regulatory filings are expected in fall 2009. Key Findings from the Phase 2 Study Continuation Through Three Years
The evidence of sustained clinical effect in belimumab-treated patients from Week 52 to Week 160 includes:
About the Phase 2 Study of LymphoStat-B in SLE
In June 2006, HGS reported the 52-week results of the Phase 2 trial, which demonstrated that belimumab significantly reduced disease activity versus placebo in patients with serologically active SLE across multiple clinical measures, exhibited clinically relevant biological activity, and appeared generally safe and well tolerated. Frequency and severity of adverse events were similar to placebo. Among the findings at Week 52 was a significantly improved response rate among serologically active patients, as defined by an improvement in SELENA SLEDAI score of 4 points or greater, no new BILAG A flare and no more than one new BILAG B flare, and no worsening in Physician’s Global Assessment. This combination of measures is the primary efficacy endpoint in the ongoing pivotal Phase 3 clinical trials. About LymphoStat-B (belimumab)
In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Pre-clinical and clinical studies demonstrate that B-cell antagonists can reduce autoantibody levels and help control autoimmune disease activity. About Human Genome Sciences
The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated diseases. The Company’s primary focus is rapid progress toward the commercialization of its two key lead drugs, Albuferon® (albinterferon alfa-2b) for hepatitis C and LymphoStat-B® (belimumab) for lupus. Phase 3 clinical trials of both drugs are ongoing. ABthrax™ (raxibacumab) is in late-stage development for the treatment of inhalation anthrax, and the Company is on track to begin the delivery in fall 2008 of 20,000 doses of ABthrax to the Strategic National Stockpile under a contract entered into with the U.S. Government in June 2006. Other HGS drugs in clinical development include two TRAIL receptor antibodies and a small-molecule antagonist of IAP (inhibitor of apoptosis) proteins for the treatment of cancer. In addition, HGS has substantial financial rights to three products in the GlaxoSmithKline clinical development pipeline. To view the EULAR oral presentation reporting results of the Phase 2 long-term continuation study of LymphoStat-B through three years, click here. To view the EULAR poster presentation reporting the safety profile of LymphoStat-B through three years, click here. To view the EULAR poster presentation reporting the progressive normalization of autoantibody, immunoglobulin and complement levels over three years of treatment with LymphoStat-B, click here. To view the EULAR poster presentation reporting evidence of LymphoStat-B’s potential steroid-sparing activity, click here. For more information on LymphoStat-B, visit www.hgsi.com/belimumab.html. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org or the European Lupus Erythematosus Federation at www.elef.rheumanet.org . For more information about HGS, visit www.hgsi.com. Health professionals or patients interested in clinical trials of HGS products may inquire via email to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it , or by calling (301) 610-5790, extension 3550. HGS, Human Genome Sciences, ABthrax, Albuferon, BLyS and LymphoStat-B are trademarks of Human Genome Sciences, Inc. Safe Harbor Statement
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