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Rigel Expects R788 Partnership After Phase 2b Clinical Trials Results
Date:2/3/2009

al results, will better position us to secure an optimal partnership arrangement for R788," said James M. Gower, Chairman and Chief Executive Officer. As for the program cuts, Mr. Gower said, "Rigel has been blessed with a prolific research organization whose members are dedicated and talented professionals. However, we have come to the point in time, where we can no longer continue to support all of the programs we have generated. The company needs to focus on moving our most advanced projects forward, including, in the case of R788, potentially into Phase 3 clinical trials."

Update on the Phase 2b, TASKi2 and TASKi3, Clinical Trials:

Enrollment for the TASKi2 clinical trial of R788 in patients with rheumatoid arthritis (RA) who have previously failed to respond to methotrexate treatment was completed in December 2008, with 457 patients randomized. The smaller TASKi3 clinical trial of R788 is on track to complete enrollment in April 2009 with an expected enrollment of 195 patients with RA who have previously failed to respond to at least one marketed biologic treatment. Both clinical trials are multi-center, randomized, double-blind, and placebo controlled.

The primary objectives for TASKi2 and TASKi3 are to measure the efficacy of R788 at 6 months and 3 months, respectively, as determined by ACR20 scores (American College of Rheumatology responder rates showing a minimum of 20% improvement in RA symptoms and pain). Secondary objectives will include comparing higher ACR response rates (ACR 50 and ACR 70), as well as DAS28 rates (Disease Activity Score including a 28-joint inspection), in addition to various safety measures. TASKi3 will also include measurement of changes in bone morphology using magnetic resonance imaging (MRI) scans as a secondary measure. In addition, Rigel will continue to develop R788 in various lymphomas and is currently conducting a clinical trial in T-cell lymphoma.'/>"/>

SOURCE Rigel Pharmaceuticals, Inc.
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