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R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent
Date:7/23/2009

to discuss these results (see conference call details below).

"Our objective with R788 in RA is to position the product after methotrexate and before biological therapies are used. We have shown excellent results in that patient population in our earlier TASKi1 and TASKi2 studies, and we believe that patient population represents the large market opportunity for this product," said James M. Gower, chairman and chief executive officer of Rigel. "In this TASKi3 patient population, biologic failures, we have seen divergent results as sometimes happens in studies with subjective components. However, we are pleased to see excellent results in the objective measures and in the Synovitis and Osteitis MRI scores," he added.

*blood measurements of C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR)

    Efficacy Results

    Treatment  N of Pts     ACR 20       ACR 50       ACR 70     DAS28<2.6
    ---------  --------     ------       ------       ------     ---------
    Placebo          73     27 (37%)      9 (12%)       4 (6%)      6 (10%)
    -------         ---     -------       ------        -----       ------
    100 mg bid      146     56 (38%)     32 (22%)      13 (9%)     15 (12%)
                             p=0.84       p=0.09       p=0.37       p=0.15
    ----------      --- ------------ ------------ ------------  -----------

    p=values compared to placebo
    Note: At 3 months. All patients were on stable doses of methotrexate
          throughout the clinical trial.



    MRI Results

    TASKi3 Mean Change from Baseline in RAMRIS* Scores at Month 3

                  Placebo      100 mg bid         p=values
                  -------      ----------         --------
    Synovitis**     +0.35            -0.52         p=0.038
    ----------      -----            -----         -------
    Osteitis**
     Score          +1.17            -0.19        
'/>"/>
SOURCE Rigel Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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