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HGS announces positive Phase 2 LymphoStat-B at ACR meeting
Date:11/9/2007

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 Physicians 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 (>4-pt reduction).

  • A sustained improvement in the percentage of serologically active patients who experienced no new BILAG A organ flare and no more than one new BILAG B organ flare (92% at Week 52; 94% at Week 128).

  • A sustained improvement in the percentage of serologically active patients showing no worsening in SLE disease activity, as measured by the Physicians Global Assessment (<.03-pt worsening 90% at Week 52 and 91% at Week 128).

  • A decrease over time in the overall frequency of SLE disease flares, and in the frequency of severe disease flares, in patients who remained on LymphoStat-B through 2.5 years, as
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Contact: Jerry Parrot
Jerry_Parrott@hgsi.com
301-315-2777
Edelman Public Relations
Source:Eurekalert

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