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| HUMAN GENOME SCIENCES INITIATES PHASE 2 CLINICAL TRIAL OF LYMPHOSTAT-B FOR THE TREATMENT OF RHEUMATOID ARTHRITIS | |
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ROCKVILLE, Maryland – January 8, 2004 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that it has begun dosing patients in a Phase 2 clinical trial of LymphoStat-B™ (human monoclonal antibody to B-lymphocyte stimulator, BLyS™) for the treatment of rheumatoid arthritis. The double-blind, placebo-controlled, multi-center Phase 2 clinical trial will evaluate the safety, optimal dosing, and efficacy of LymphoStat-B in patients with rheumatoid arthritis. Approximately 230 patients with active rheumatoid arthritis who have failed prior therapy will be enrolled in the trial and randomized to receive intravenously 1 mg/kg, 4 mg/kg, or 10 mg/kg of LymphoStat-B or placebo every four weeks over a 24-week treatment period. Efficacy will be evaluated according to the American College of Rheumatology (ACR) criteria for defining clinical improvement in rheumatoid arthritis patients. The primary efficacy endpoint for the LymphoStat-B Phase 2 trial will be the rate of response at week 24 (i.e., the percentage of patients who achieve at least 20% improvement on the ACR-specified measures of disease activity). Safety, pharmacokinetics, and changes in quality of life also are being evaluated. William Stohl, M.D., Ph.D., Professor of Medicine, Division of Rheumatology, University of Southern California, said, “Rheumatoid arthritis is a systemic, chronic autoimmune disease that affects over two million people in the United States alone. The disease is characterized by inflammation of the joints, which is caused by the body’s own immune system attacking healthy joint tissue. Preclinical and early clinical data suggest that B cells may have an important contributory role in the pathogenesis of autoimmune diseases such as rheumatoid arthritis. We look forward to evaluating LymphoStat-B’s potential to offer a new treatment option to patients suffering from this disease.” David C. Stump, M.D., Executive Vice President, Drug Development, said, “We are pleased to advance LymphoStat-B into Phase 2 clinical trials for the treatment of rheumatoid arthritis. Results of observational studies show that BLyS levels are elevated in the blood and joint fluid of patients with rheumatoid arthritis, and are positively correlated with levels of immunoglobulin-G and of the autoantibody, rheumatoid factor. In rheumatoid arthritis, autoantibody levels – especially rheumatoid factor – appear to correlate with rheumatoid arthritis disease severity. Emerging clinical and preclinical evidence suggest that B cell antagonists, such as LymphoStat-B, have the potential to reduce autoantibody levels and help reduce disease progression. Preclinical and clinical results to date indicate that LymphoStat-B is well tolerated and capable of reducing levels of CD20 B cells. The Phase 2 study of LymphoStat-B in patients with rheumatoid arthritis and an ongoing Phase 2 study in patients with systemic lupus erythematosus are designed to provide definitive data on the safety and efficacy of LymphoStat-B in patients suffering from these autoimmune diseases.” William A. Haseltine, Ph.D., Chairman and CEO, said, “Several million people suffer from rheumatoid arthritis worldwide. Emerging research suggests that B cells may play an important role in the pathogenesis of rheumatoid arthritis. We believe that, by inhibiting BLyS’s stimulation of B-cell development, LymphoStat-B may be able to help reduce the progression of disease in these patients and improve their quality of life.” 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.1 Plasma B cells produce antibodies, the body’s first line of defense against infection. Laboratory studies have indicated that higher than normal levels of BLyS may contribute to the pathogenesis of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus.2, 3, 4, 5 Autoimmune diseases are diseases in which the body is attacked by its own immune system. In rheumatoid arthritis, 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. In rheumatoid arthritis, autoantibody levels – especially rheumatoid factor – appear to correlate with disease severity.6 Retrospective studies have shown elevated levels of BLyS in the blood and joint fluid of patients with rheumatoid arthritis and in the blood of many patients with systemic lupus erythematosus.6, 7, 8, 9, 10 Preclinical and clinical studies demonstrate that B cell antagonists can reduce autoantibody levels and help control rheumatoid arthritis disease activity.5, 11, 12 LymphoStat-B acts by: (1) binding to BLyS, (2) inhibiting BLyS’s stimulation of B-cell development, and (3) restoring the potential for autoantibody-producing B cells to undergo the normal process of apoptosis (programmed cell death).13 Clinical and preclinical studies indicate that LymphoStat-B is well tolerated and capable of reducing levels of antibody-producing B cells.14, 15, 16 LymphoStat-B was created through a collaboration between Human Genome Sciences and Cambridge Antibody Technology. Human Genome Sciences holds exclusive commercial rights to the drug. Rheumatoid arthritis is a systemic, chronic autoimmune disease. Rheumatoid arthritis affects approximately 2.1 million Americans, mostly women. Rheumatoid arthritis is characterized by the inflammation of the membrane lining the joint, caused by the body’s own immune system attacking healthy joint tissue. Symptoms typically begin during middle age and may include inflammation of joints, swelling, difficulty moving, and pain. Daily joint pain frequently results in limited movement and interferes with a person’s ability to carry out normal activities. For more information on LymphoStat-B, see www.hgsi.com/products/LSB.html. For more information on lupus, rheumatoid arthritis, or autoimmune diseases, visit the Arthritis Foundation at www.arthritis.org, the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov, or The Lupus Foundation of America at www.lupus.org. For additional information on Human Genome Sciences, please visit our web site at www.hgsi.com. For more information on the clinical trials evaluating LymphoStat-B, visit www.clinicaltrials.gov. Health professionals or patients interested in inquiring about the LymphoStat-B trials or any other study involving HGSI products are encouraged to inquire via the Contact Us section of the Human Genome Sciences web site, www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550. Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients. 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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