Leading the way to a cure

Lupus Research Update: 2006 Volume 3

Volume 3, 2006 - Online Edition | In This Issue

Meet the Investigator >
Pilot Grant Program >
Research Results - Using Cholesterol Levels to Screen for Worsening Lupus-Related Kidney Disease >
Research Results - New Genetic Findings Linked to Lupus in Mouse Models >
Research Results - Rituximab for Lupus Shows Promise >
Research Results - New Target for Treatment Identified >
Advocacy Update - Senator Charles Schumer Champions Lupus Research >
Beyond the Research - The ALR Walks Nationwide >
Drug Research and Development News >

Drug Research and Development News

Human Genome Preparing Phase III Trials for LymphoStat-B

Human Genome Sciences Inc., (HGS) announced in June that Phase II trials of its LymphoStat-B (belimumab) lupus treatment showed it was safe and well tolerated, and significantly reduced disease activity in patients with active systemic lupus erythematosus (SLE). Belimumab is a human monoclonal antibody—a synthetic clone of an antibody—that inhibits the activity of B-lymphocyte stimulator (BLyS), a protein required forB cells to mature. Preclinical and clinical studies show that belimumab and other similar B-cell antagonists like it can reduce autoantibody levels and help control autoimmune disease activity.

Human Genome Sciences is developing LymphoStat-B with GlaxoSmithKline (GSK). The two companies received a Fast Track designation from the Food and Drug Administration for the drug based on its potential for treating SLE. They expect to begin Phase III trials before the end of 2006.

Preliminary Results from Atacicept (TACI-Ig) Phase 1b Study Released

ZymoGenetics, Inc., announced preliminary results from two Phase Ib clinical trials in patients with active systemic lupus erythematosus (SLE) showed its drug, atacicept, has potential for treating patients with SLE. The drug was well tolerated across all dose levels and schedules tested, with clear biologic response corresponding to its known mechanism of action.

Atacicept is a soluble receptor that binds to cytokines that promote B-cell survival and the production of autoantibodies associated with SLE.

ZymoGenetics, which is developing the drug in conjunction with Serono S.A., plans to start a Phase II study of the drug later this year in rheumatoid arthritis patients.

Riquent Marketing Authorization Application Accepted by European Authorities

La Jolla Pharmaceutical Company announced in June that its Marketing Authorization Application (MAA) for the lupus renal disease drug Riquent (abetimus), filed with the European Union (EU) in March, had been accepted for review. If approved, La Jolla will be able to market the drug in all 25 EU member nations as well as Norway, Iceland and Lichtenstein. Riquent is the first drug specifically developed for the treatment of lupus kidney disease. It has been evaluated in 13 clinical trials during the past decade involving more than 800 patients. The drug reduces antibodies to the autoantibody dsDNA, frequently associated with lupus nephritis. Studies show that the lower the antibody

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