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Human Genome Sciences Reports Progress With Late-Stage Products and New Initiatives
Date:5/28/2008

y control disease symptoms and progression. HGS market research suggests that LymphoStat-B, assuming Phase 3 trials are successful, could play a major role in the treatment of SLE, with a differentiated profile for use in chronic therapy.

Key milestones leading to a potential U.S. launch of LymphoStat-B in 2010:

-- Complete enrollment and initial dosing in BLISS-76, one of two Phase 3

trials of LymphoStat-B in patients with active SLE, by the end of

summer 2008.

-- First Phase 3 data available by mid-2009 (from BLISS-52), the second

Phase 3 trial of LymphoStat-B in patients with active SLE.

-- All Phase 3 data available in fall 2009.

-- Planned filing of a Biologics License Application (BLA) in early 2010.

HGS today also announced that HGS and GSK have agreed to initiate a Phase 2 trial of LymphoStat-B for use in the treatment of multiple sclerosis (MS). Patients with MS continue to have unmet medical needs despite the treatments currently available. The scientific rationale for testing LymphoStat-B in MS is strong, since the drug acts by inhibiting the activity of BLyS(TM), a protein discovered by HGS, which is found at elevated levels in MS lesions and is associated with the MS disease process. In addition, the results of a Phase 2 trial of rituximab provided clinical validation for B-cell modulation in the treatment of relapsing-remitting MS.

ABthrax(TM) (raxibacumab), a human monoclonal antibody that prevents anthrax toxins from entering and killing cells, for the treatment of anthrax disease

HGS reported in December 2007 that the results of two animal studies demonstrated the life-saving potential of ABthrax in the treatment of inhalation anthrax. The results show that a single dose of ABthrax, administered without the use of antibiotics, improved survival rates by up to 64 percent when administered after animals were already showing symptoms of anthrax disease as a result of
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SOURCE Human Genome Sciences, Inc.
Copyright©2008 PR Newswire.
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