Human Genome Sciences, Inc, announced plans to initiate in 2006 a phase III clinical trial of LymphoStat-Bâ„¢ (belimumab), a human monoclonal antibody that neutralizes B-lymphocyte stimulator (BLySâ„¢), in patients with systemic lupus erythematosus (SLE). 

The study will be conducted in collaboration with GlaxoSmithKline (GSK), which last July exercised its option under a 1996 agreement to develop and commercialize LymphoStat-B jointly with Human Genome Sciences. Under the terms of the agreement, GSK and Human Genome Sciences will share equally in phase III/IV development costs, and in sales and marketing expenses and profits of any product that is commercialized under the agreement.

The US Food and Drug Administration has included LymphoStat-B for the SLE indication in its Continuous Marketing Application Pilot 2 Program and designated the biologic as a Fast Track Product.

Human Genome Sciences, based in Rockville, Maryland, is also developing LymphoStat-B for use in treating rheumatoid arthritis and potentially other indications.

―A. Techman