Rigel's R788 Phase 2a Results Published in Arthritis and ... ( First of Phase 2b studies complet...)

Rigel's R788 Phase 2a Results Published in Arthritis and Rheumatism

Date:11/11/2008

First of Phase 2b studies completes patient screening for enrollment

SOUTH SAN FRANCISCO, Calif., Nov. 11 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the previously reported results of the Phase 2 clinical trial of R788 (fostamatinib disodium), the company's oral Syk inhibitor, have been published in the November 2008 issue of Arthritis and Rheumatism. The article, entitled, "Treatment of rheumatoid arthritis with a syk kinase inhibitor: A twelve-week, randomized, placebo-controlled trial" was written by Michael E. Weinblatt, M.D., et al.

The investigators for this study, also called TASKi1, which enrolled 189 patients with active rheumatoid arthritis (RA) already taking methotrexate for their disease, found that the 100 mg and 150 mg doses of R788 showed rapid and significant improvement in patient outcomes as measured by ACR 20, ACR 50 and ACR 70 response scores. The adverse events reported were manageable and, in large part, reversible by reduced dosing or stoppage of drug. The investigators concluded that R788 may offer a new therapeutic option for patients with RA and that additional clinical studies were warranted.

Phase 2b update

In June 2008, Rigel initiated two Phase 2b trials of R788 in patients with RA, TASKi2 and TASKi3, to further explore the safety and efficacy of the drug candidate in a larger number of patients over a longer time period in multiple centers in North America, Latin America and Europe. "At this time, we are pleased to report that we have successfully completed patient screening for enrollment in TASKi2 and are proceeding with both Phase 2b trials on schedule," commented Elliott Grossbard, M.D., executive vice president and chief medical
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