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| HUMAN GENOME SCIENCES REPORTS RESULTS OF A PHASE 2 CLINICAL TRIAL OF LYMPHOSTAT-B IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS | |
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- Overall primary efficacy endpoints not met - ROCKVILLE, Maryland – October 5, 2005 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the results of a Phase 2 clinical trial demonstrated that LymphoStat-B™ (belimumab) was safe, well tolerated, and showed signs of clinical effect in patients with systemic lupus erythematosus (SLE), although the drug did not meet the overall primary efficacy endpoints of reducing the signs and symptoms of SLE at Week 24 as measured by SELENA SLEDAI 1-2, or increasing the time to first SLE flare over 52 weeks. LymphoStat-B reduced the signs and symptoms of SLE at Week 52 at a level of statistical significance in seropositive patients, a subgroup that represented 75% of the study’s patient population, as measured by both SELENA SLEDAI (p=0.021) and the Physician’s Global Disease Assessment (p=0.016). Trends to greater reduction in prednisone therapy also were observed across the active study population. As anticipated based on preclinical and clinical research to date3-10, results demonstrated that LymphoStat-B produced targeted and statistically significant reductions versus placebo in all active-treatment arms in both circulating B cells (CD 20 + and other subsets) and anti-dsDNA autoantibodies. The results in active treatment groups showed a 29% median reduction in anti-dsDNA autoantibodies among patients positive for anti-dsDNA at baseline (p=0.0018), and a 33% median increase in C4 complement at Week 52 among patients with low C4 at baseline (p=0.014). No dose response was observed. Signs of drug activity were observed across the range of doses studied, including the lowest dose of 1 mg/kg. Results further showed that LymphoStat-B was well tolerated with no clinically significant differences from placebo in adverse events, serious adverse events or laboratory abnormalities. Clinically significant infusion reactions were rare, and no differences from placebo were observed in infection rates. The double-blind, placebo-controlled, dose-ranging Phase 2 trial was designed to evaluate the safety, optimal dosing and efficacy of LymphoStat-B, a human monoclonal antibody to B-lymphocyte stimulator (BLyS™), in patients with SLE. 11-12 The study was conducted at multiple centers in the United States and Canada. A total of 449 patients with active SLE were randomized to receive one of three different doses (1, 4 or 10 mg/kg) of LymphoStat-B or placebo administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy. All patients in the study were dosed on Days 0, 14 and 28, then every 28 days for the remainder of the 52 weeks. The study design included concurrent standard-of-care therapy. 82% of the patients were receiving background prednisone therapy, either alone or in combination. The primary efficacy endpoints were the SELENA SLEDAI score at Week 24 and time to first SLE disease flare over 52 weeks (as defined by the SLE Flare Index). Secondary efficacy and biological endpoints, as well as safety, also were evaluated.
David C. Stump, M.D., Executive Vice President, Drug Development, said, “I am encouraged by the substantial evidence of LymphoStat-B’s clinical activity that has emerged from this Phase 2 trial in patients with systemic lupus erythematosus. The statistically significant clinical effect of LymphoStat-B in the seropositive subpopulation is interesting, given the greater disease activity that is observable in these patients, who represent 75% of the study’s patient population. The results add substantively to the evidence of LymphoStat-B’s biological activity, as demonstrated by the targeted and statistically significant reductions in levels of circulating CD 20 + and other B-cell subsets, and in anti-dsDNA autoantibody levels. Very importantly, the data confirm and extend previous clinical results by demonstrating that LymphoStat-B was safe and well tolerated during this 52-week exposure period. We have learned a great deal about the clinical endpoints currently available for the evaluation of new therapies for SLE, and about the specific nature of their interaction with LymphoStat-B in various subpopulations of lupus patients. We now have the data that I believe support our proceeding on a path toward Phase 3 development of LymphoStat-B for the treatment of SLE. I look forward to the full presentation of these data at an appropriate scientific meeting in the coming months, and most importantly to the opportunity to continue the development of what we hope will become an important therapeutic option for patients suffering from this often debilitating disease.” GlaxoSmithKline has exercised its option under a June 1996 agreement to develop and commercialize LymphoStat-B jointly with Human Genome Sciences. Under the terms of the agreement, GSK and Human Genome Sciences will share equally in Phase 3/4 development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized under the agreement, under a co-development and co-promotion agreement, the remaining terms of which are being negotiated by the parties. 13 Systemic lupus erythematosus (SLE) is a chronic, life-threatening disease. Between 200,000 and 500,000 people are diagnosed with SLE in the United States alone. The Lupus Foundation of America estimates that approximately 1.5 million Americans suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people between the ages of fifteen and forty-five. About 90 percent of the individuals diagnosed with lupus are women. African American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash, and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels, and blood disorders. LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. BLyS is a naturally occurring protein discovered by Human Genome Sciences that is required for the development of B-lymphocyte cells into mature plasma B cells. 14-15 Plasma B cells produce antibodies, the body’s first line of defense against infection. Retrospective and prospective studies have shown elevated levels of BLyS in the blood of many patients with systemic lupus erythematosus, and in the blood and joint fluid of patients with rheumatoid arthritis. In lupus, rheumatoid arthritis, 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. Preclinical and clinical studies demonstrate that B-cell antagonists can reduce autoantibody levels and help control autoimmune disease activity. LymphoStat-B is a Human Genome Sciences drug, created through a collaboration with Cambridge Antibody Technology. 16 Human Genome Sciences is a company with the mission to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs. CONFERENCE CALL Human Genome Sciences management will hold a conference call to discuss this announcement today at 10:00 am Eastern Time. Investors may listen to the call by dialing 800/811-0667 or 913/981-4901, confirmation code 1295470, five to ten minutes before the start of the call. A replay of the conference call will be available for several days by dialing 719/457-0820 or 888/203-1112, confirmation code 1295470. This conference call also will be webcast. Interested parties who wish to listen to the webcast should visit the Human Genome Sciences website at www.hgsi.com. The archive of the conference call will be available several hours after the conference call and will be available for several days. For more information on LymphoStat-B, see www.hgsi.com/products/LSB.html. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org , or the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov. For additional information on Human Genome Sciences, please visit our web site at www.hgsi.com. Health professionals or patients interested in inquiring about LymphoStat-B trials or any other study involving Human Genome Sciences products are encouraged to inquire via the Contact Us section of the company’s web site, www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550. HGS, Human Genome Sciences, BLyS and LymphoStat-B are trademarks of Human Genome Sciences, Inc. This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise. ### Footnotes:
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