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Biotech / Medical : Human Genome Sciences, Inc. (HGSI) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (660)	11/14/2001 3:43:47 PM
From: tuck	Read Replies (1) \| Respond to of 1127

>>ROCKVILLE, Md., Nov. 14 /PRNewswire/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - news) announced today that data presented at this week's American College of Rheumatology Annual Meeting in San Francisco support the potential of LymphoStat-B(TM), a human monoclonal antibody targeting BLyS(TM) (B lymphocyte stimulator), as a treatment for autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis and Sjogren's syndrome. Three abstracts were presented this week that highlight the role of elevated BLyS levels in patients with certain autoimmune diseases, as well as the potential of a BLyS antagonist as a promising therapeutic approach. The Role of BLyS in Autoimmune Diseases Results from a study investigating the levels of BLyS in the joints and serum of inflammatory arthritis patients compared to osteoarthritis or traumatic arthritis patients to better understand the role of BLyS in chronic inflammatory arthritis were presented on Wednesday, November 14. The results of this study demonstrated that serum and synovial (joint) fluid BLyS levels in patients with inflammatory arthritis were each significantly greater than BLyS levels in the serum or synovial fluid of patients with osteoarthritis or traumatic arthritis (p<0.0001 and 0=0.043, respectively). In addition, BLyS levels were significantly greater in the synovial fluid when compared to serum BLyS levels in each patient group. The results of this study suggest that local production of BLyS in the synovial fluid may play a significant role in chronic inflammatory arthritis, including rheumatoid arthritis(1). Results from a study to determine the role of elevated BLyS levels in patients with Sjogren's syndrome were presented on Tuesday, November 13. Measurements of serum from 49 patients demonstrated that BLyS levels were significantly increased in patients with Sjogren's syndrome as compared to control patients (p<0.0001). Additionally, increased BLyS levels were significantly associated with common disease markers, including the presence of anti-Sjogren's syndrome-A/anti-Sjogren's syndrome-B antibodies (p=0.008), the presence of rheumatoid factor (pp=0.03), the level of immunoglobulin M (IgM) (p<0.0001) and the level of rheumatoid factor (p<0.0001). These data indicate that BLyS may play a critical role in triggering autoantibodies -- antibodies that target the body's own cells and tissues -- in patients with Sjogren's syndrome(2). BLyS Antagonist as a Therapeutic On Wednesday, November 14, data were presented on the preclinical validation of a human monoclonal antibody targeting BLyS to inhibit the elevated BLyS levels seen in many systemic lupus erythematosus and rheumatoid arthritis patients(3). In vitro activity and in vivo pharmacology results from studies in mice support the development of a fully human monoclonal antibody as a novel treatment approach to effectively inhibit BLyS-driven B cell autoimmune diseases(4). David C. Stump, M.D., Senior Vice President of Drug Development Human Genome Sciences, said, ``The results from these and other data presented at this week's meeting provide additional evidence for developing LymphoStat-B, a novel approach for treating B cell-mediated autoimmune diseases. If the initial Phase 1 trials of the drug are successful, we hope to be able to add new indications for additional trials for patients with rheumatoid arthritis and other autoimmune diseases, such as immune thrombocytopenic purpura, and Sjogren's syndrome. These studies should also shed much light on the role of hyperactive B-cell immunity, and of BLyS in particular, in the origin of a broad family of autoimmune diseases.'' In a November 1, 2001 announcement, Human Genome Sciences said that the U.S. Food and Drug Administration (FDA) had approved the company's investigational new drug (IND) application to begin clinical trials of LymphoStat-B, as a potential new treatment for autoimmune diseases. The company is moving forward with plans to initiate a multi-center, dose- escalation Phase 1 trial in patients with mild to moderate systemic lupus erythematosus. William A. Haseltine, Ph.D., Chairman and Chief Executive Officer, Human Genome Sciences, said, ``We are moving forward with our plans to begin trials of LymphoStat-B in the treatment of systemic lupus erythematosus and other autoimmune diseases. These diseases cause immense suffering to millions of patients worldwide, and we are pleased that LymphoStat-B may provide a new and rational, mechanism-based approach for the treatment of these diseases.''<< snip Cheers, Tuck