Human Genome seeks approval for lupus drug trial
Date: 17.8.2006
If the U.S. Food and Drug Administration approves Human Genome's proposal for the design of its Phase III clinical trial, the company could begin enrollment by the end of this year.
This is the first time Human Genome Sciences has brought a drug this far along in the development process. The drug, LymphoStat-B, is monoclonal antibody that inhibits the biological activity of a protein that is required for the development of mature plasma B cells.
These cells produce antibodies, which are the body's first line of defense against infection.
Between 200,000 and 500,000 Americans are diagnosed with systemic lupus erythematosus each year. About 1.5 million Americans suffer from lupus of various forms. The disease can cause fatigue, swollen joints, kidney failure, heart and lung inflammation and blood disorders.
The company said it expects to receive $24 million in the third quarter of this year under a co-development and co-commercialization agreement with GlaxoSmithKline Plc.
"Source":[ http://today.reuters.com/news/articlenews.aspx?storyID=2006-08-09T130001Z_01_N09332422_RTRUKOC_0_US-HUMANGENOME.xml&rpc=81]
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