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| HUMAN GENOME SCIENCES COMPLETES PATIENT ENROLLMENT IN A PHASE 2 CLINICAL TRIAL OF LYMPHOSTAT-B FOR THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS | |
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ROCKVILLE, Maryland – July 29, 2004 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that it has completed the enrollment, randomization and initiation of dosing of patients in a Phase 2 clinical trial of LymphoStat-B™ (human monoclonal antibody to B-lymphocyte stimulator, BLyS™) for the treatment of systemic lupus erythematosus. The double-blind, placebo-controlled, multi-center Phase 2 clinical trial is designed to evaluate the safety, optimal dosing, and efficacy of LymphoStat-B. A total of 449 patients with active systemic lupus erythematosus have been enrolled in the trial and randomized to receive one of three different doses of either LymphoStat-B or placebo over a 52-week treatment period, in addition to standard-of-care therapy. Efficacy will be measured in the trial according to scores on the SELENA SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) and BILAG (British Isles Lupus Activity Group) SLE disease activity scales. Time to first lupus disease flare also will be measured. LymphoStat-B has received a Fast Track Product designation from the U.S. Food and Drug Administration (FDA) for its potential use in treating systemic lupus erythematosus1 and has been selected for participation in FDA’s Continuous Marketing Application Pilot 2 Program.2 Human Genome Sciences also has completed the enrollment, randomization and initiation of dosing of a Phase 2 clinical trial of LymphoStat-B for the treatment of rheumatoid arthritis (the subject of a separate press release distributed today).3 Results from a Phase 1 clinical trial presented at the American College of Rheumatology annual meeting in October 2003 demonstrate that LymphoStat-B is well tolerated and biologically active in patients with systemic lupus erythematosus.4 The results show no clinically significant differences from placebo in adverse events or laboratory abnormalities. No drug-related serious adverse events were reported. The half-life of LymphoStat-B was shown to be consistent with that of other human monoclonal antibodies, and a dose-proportional pharmacokinetic profile was observed. As expected based on preclinical research, the Phase 1 results show that LymphoStat-B significantly reduces the levels of circulating B (CD 20) cells, the precursor cells to those that produce the body’s normal and abnormal antibodies. Daniel J. Wallace, M.D., Clinical Professor of Medicine, David Geffen School of Medicine, UCLA (based at Cedars-Sinai Medical Center, Los Angeles), said, “Lupus is a complex and often devastating chronic illness that can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels, and blood disorders. It can occur at any age, but appears mostly in young women between the ages of fifteen and forty-five. Only a limited number of treatment options are currently available to patients with lupus, and there is a significant need for new treatments that can help control disease progression and improve the quality of life. Laboratory studies have indicated that higher than normal levels of BLyS may contribute to the pathogenesis of autoimmune diseases, such as systemic lupus erythematosus.5, 6, 7, 8 We look forward to continuing to elucidate the potential use of LymphoStat-B for the treatment of systemic lupus erythematosus.” Sandra C. Raymond, President and Chief Executive Officer, Lupus Foundation of America, said, “It has been nearly forty years since a new drug has been approved for lupus. We need safer, more effective therapies for this life-threatening disease. The LymphoStat-B Phase 2 clinical trial is one of the largest ever conducted in lupus patients, and we will be following it with great interest, particularly since LymphoStat-B is intended to treat the underlying disease of lupus, rather than treating an individual symptom.” David C. Stump, M.D., Executive Vice President, Drug Development, said, “We are pleased to have completed the enrollment of our Phase 2 clinical trial of LymphoStat-B for the treatment of systemic lupus erythematosus. The continued high level of support and enthusiasm for LymphoStat-B in the investigator and patient advocacy community made rapid progress possible. In addition, LymphoStat-B’s Fast Track status and its selection for the FDA’s Continuous Marketing Application Pilot 2 Program allowed us to work closely with the FDA following completion of the Phase 1 trial. The Phase 2 study will evaluate LymphoStat-B’s safety, optimal dosing, and efficacy. We expect that results will be available in the Fall of 2005. Given the number of patients enrolled and the study’s greater than eighty percent statistical power to detect a clinically meaningful benefit, we are confident that the results will be very informative for a decision on LymphoStat-B’s further development. We look forward to that important milestone for the clinical development of LymphoStat-B as a potential treatment for lupus and certain other autoimmune diseases.” 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.9 Plasma B cells produce antibodies, the body’s first line of defense against infection. 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. Preclinical and clinical studies demonstrate that B-cell antagonists can reduce autoantibody levels and help autoimmune disease activity.8, 17, 18 Retrospective and prospective studies have found elevated levels of BLyS in the blood of many patients with systemic lupus erythematosus.10, 11, 12, 13, 14 The results of prospective studies now show a significant correlation of elevated levels of BLyS with systemic lupus erythematosus disease activity.15, 16 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). 19 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.
Systemic lupus erythematosus is a serious, life-threatening disease. Between 200,000 and 500,000 people are diagnosed with systemic lupus erythematosus in the United States alone. The disease affects between eight and ten times as many women as men. It can occur at any age, but appears mostly in young people between the ages of fifteen and forty-five. 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 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:
1. (HGSI Press Release) Results Of Phase 1 Clinical Trial Demonstrate That LymphoStat-B Is Safe And Biologically Active In Patients With Systemic Lupus Erythematosus. April 21, 2003.
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