Human Genome Sciences and GlaxoSmithKline have begun dosing for BLISS-52, the second of two Phase III trials of LymphoStat-B in patients with active systemic lupus erythematosus (SLE). Dosing in BLISS-76, the first Phase III trial of the drug, began in February 2007. LymphoStat-B is being developed by the companies under a definitive development and commercialization agreement initiated in August 2006.

"We believe that LymphoStat-B could address the significant medical need of patients suffering from SLE, and we are pleased to announce that both Phase III trials of this novel and potentially important compound are now underway," said H. Thomas Watkins, president and chief executive officer, HGS. "These trials, assuming that they are successful, will provide the pivotal data to support global marketing applications for LymphoStat-B."

BLISS-52 is being conducted primarily in Asia, South America and Eastern Europe, while BLISS-76 is being conducted primarily in North America and Europe.

"There is a great need for safer and more effective treatments for lupus," said Professor Sandra V. Navarra, M.D., a principal investigator and head of Rheumatology at the University of Santo Tomas, Manila, Philippines. "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 these trials."

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