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news.Human Genome Sciences has started dosing in its second phase III clinical trial of its novel compound LymphoStat-B in patients with active systemic lupus erythematosus.
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LymphoStat-B, a human monoclonal antibody, is being developed by Human Genome Sciences (HGS) and GlaxoSmithKline under a definitive development and commercialization agreement entered into in August 2006.
The trial is being conducted primarily in Asia, South America and eastern Europe. Meanwhile, dosing in the first phase III trial began in February 2007, and is being conducted primarily in North America and Europe.
The first and second phase III trials will both test the safety and efficacy of 1 mg/kg and 10 mg/kg doses of LymphoStat-B against a placebo.
HGS said that it believes LymphoStat-B could address the significant medical need of patients suffering from systemic lupus erythematosus (SLE), a chronic, life-threatening autoimmune disease.
Professor Sandra Navarra, a principal investigator and head of rheumatology at the University of Santo Tomas, Manila, Philippines, said: “The results of previous studies suggest that LymphoStat-B significantly reduced SLE disease activity in serologically active patients. We look forward to further evaluation of LymphoStat-B in larger numbers of patients in the phase III trials.”
H Thomas Watkins, president and CEO of HGS, added: “These trials, assuming that they are successful, will provide the pivotal data to support global marketing applications for LymphoStat-B.”