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Human Genome Sciences Reports Positive Data from Long-Term Treatment with LymphoStat-B(R) in Patients with Active Systemic Lupus Erythematosus
Date:11/9/2007

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Key Findings to Date from the Phase 2 Study

In June 2006, HGS reported the 52-week results of the Phase 2 trial of LymphoStat-B in patients with SLE. The 52-week results demonstrated that LymphoStat-B significantly reduced disease activity versus placebo in patients with serologically active SLE across multiple clinical measures, exhibited clinically relevant biological activity, and appeared generally safe and well tolerated. Frequency and severity of adverse events were similar to placebo, with no increase at higher doses. Among the findings at Week 52 was a significantly improved response rate among serologically active patients, as defined by an improvement in SELENA SLEDAI score of 4 points or greater, no new BILAG A flare and no more than one new BILAG B flare, and no worsening in Physician's Global Assessment (46% for LymphoStat-B versus 29% for placebo, p<0.01). This combination of measures is the primary efficacy endpoint in the ongoing pivotal Phase 3 clinical trials.

The data presented today at ACR 2007 demonstrated that LymphoStat-B achieved sustained improvement or stabilization of SLE disease activity in serogically active patients through 2.5 years. LymphoStat-B also decreased the frequency of SLE disease flares in these patients over time. The overall incidence of adverse events and laboratory abnormalities remained stable or decreased from Week 52 to Week 128.

The evidence of sustained clinical effect in serologically active SLE patients from Week 52 to Week 128 includes:

-- An increase from 46% to 54% in the combined patient response rate

selected as the primary efficacy endpoint of the Phase 3 trials. Among

serologically active subjects who completed 128 weeks of treatment

(n=175), 63% responded based on this measure of clinical effect.

-- An increase from 49% to 58% in the proportion of patients who had

improvement in SLE disease activity, as measured by SELENA SLEDAI'/>"/>

SOURCE Human Genome Sciences, Inc.
Copyright©2007 PR Newswire.
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