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Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial
Date:7/9/2009

their blood pressure was generally well controlled throughout the trial. The blood pressure medications were standard doses of common blood pressure medications such as ACE inhibitors or diuretics.

"R788 continues to perform with strong efficacy and good tolerability in the groups of patients with RA who have failed to respond to methotrexate," said Elliott Grossbard, M.D., chief medical officer for Rigel. "We now have a much better understanding of R788's safety profile and believe that the observed side effects may be effectively managed," he added.

    Safety Results Tables

    (N)                Placebo   (153)     150 mg qd (152)   100 mg bid (152)
    Dose Reductions      N         %         N        %        N        %
    # Had a Dose
     Reduction           6        4%        21      14%       21      14%
    Neutropenia
     (ANC <1500)         1        1%         6       4%        1       1%
    Diarrhea, nausea,
     vomiting, dizziness 1        1%         5       3%        9       6%
    Increase in Blood
     Pressure            2        1%         4       3%        6       4%
    ALT or Alkphos
     Elevation           2        1%         6       4%        5       3%



    Treatment Emergent Adverse Events

                         N         %         N        %        N       %
    Diarrhea             5        3%        18      12%       29      19%
    Hypertension         7        5%        18      12%       21      14%
    Infections          42       27%        37      24%       53      35%



    Mean Blood Pressure
     (Systolic/Diastolic in mmHg)           mmHg           mmHg        mmHg
    Baseline                              125/76         125/77      125/77
    At Month 6                            123/76         125/77      125/78
    Change from Baseline to
     Month 6 (LOCF)                      -1.8/+0.4     +0.2/+0.3    +0.6/+1.4



    Mean Systolic 
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SOURCE Rigel Pharmaceuticals, Inc.
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