Rigel begins phase 1 trial of R788 rheumatoid arthritis compound, files application for R763

By Angela McDaniels

Seattle, Dec. 20 - Rigel Pharmaceuticals Inc. said it has begun a phase 1 trial to investigate the safety and pharmacokinetics of R788, its product candidate for the treatment of inflammatory diseases, in combination with methotrexate in rheumatoid arthritis patients.

The double-blind, placebo controlled study will evaluate 16 patients from the United States who have stable disease. Rigel said it plans to begin efficacy studies of R788 in 2006.

R788 is an oral syk kinase inhibitor that blocks the activation of mast cells, macrophages and B cells that promote swelling and an inflammatory response.

Phase 1 trials completed to date show that R788 is well-tolerated and has good pharmaceutical properties, the company said. In preclinical studies, it greatly diminished the swelling and tissue destruction associated with rheumatoid arthritis.

Rigel also announced that it has filed an Investigational New Drug Application with the Food and Drug Administration for R763, an orally available multi-Aurora kinase inhibitor being developed to treat cancer as part of an Aurora kinase collaboration with Serono.

Geneva-based Serono is responsible for the further development and commercialization of R763, as well as any other product candidates arising from Rigel's Aurora kinase inhibitor program.

Rigel said R763 has been shown in in vitro and in vivo tumor xenograft models to inhibit proliferation and trigger cell death in several tumor cell lines including the cervix, colon, lung, pancreas and prostate.

"Our clinical and research programs continue to progress and we remain committed to our goal of initiating clinical trials with at least one new product candidate each year," chairman and chief executive officer James M. Gower said in a company news release.

Rigel is a clinical-stage drug development company based in South San Francisco that develops small-molecule drugs for the treatment of inflammatory diseases, cancer and viral diseases.

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