Biotech Tracker News - LymphoStat-B Advances
April 21, 2003, Human Genome Sciences’ (NASDAQ: HGSI) 70-patient, randomized, double-blind, placebo-controlled, dose-escalation, phase I clinical trial of LymphoStat-B in adults with systemic lupus erythematosus (SLE) has generated reassuring safety, tolerability, and pharmacological profiles. HGSI also announced that Lymphostat-B has been granted fast track status for the treatment of SLE. HGSI expects to initiate phase II clinical trials in 2003 in both SLE and rheumatoid arthritis.  The phase I SLE study subjects, who were concomitantly receiving standard therapies, were randomized to receive either intravenous LymphoStat-B or placebo. LymphoStat-B was dosed at 1, 4, 10, or 20 milligram per kilogram. Subjects received a single dose of LymphoStat-B, two doses of LymphoStat-B 21 days apart, or placebo.  In addition to achieving the reassuring primary phase I endpoints, LymphoStat-B significantly reduced CD20-positive circulating B cells, suggesting clinical potential in the management of autoimmune diseases. HGSI expects to present full results of this investigation in a peer-reviewed forum.  LymphoStat-B is a fully human antibody developed by HGSI and Cambridge Antibody Technology (NASDAQ: CATG). It targets B Lymphocyte Stimulator (BlyS), a member of the TNF family of proteins secreted by macrophages and other antigen presenting cells that stimulate B cell proliferation.
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