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RIGEL INITIATES PHASE II ALLERGY TREATMENT TRIAL

August 9, 2005

Rigel Pharmaceuticals has enrolled the first patient in a comparative Phase II clinical study of R112, a potential intranasal therapy for the treatment of allergic rhinitis.

Allergic rhinitis causes chronic congestion and general inflammation of the upper respiratory tract in more than 59 million people in the U.S. R112 inhibits mast cell activation, thereby blocking the major pathways triggered in an allergic attack. This trial, which is expected to enroll approximately 375 patients, will be a randomized, double-blind study comparing R112 to placebo and Beconase AQ (beclomethasone) nasal spray over a seven-day period.

The Phase II trial will enroll patients who have experienced seasonal allergic rhinitis during the summer/fall pollen season for the last two years. The primary endpoints are safety and efficacy, as measured by a total nasal symptom severity rating scale, a scale of five nasal symptoms including congestion, runny nose, sneezing, itchy nose and postnasal drip. The trial consists of a screening period during which the patients must stop taking any allergy medications, followed by a placebo run-in period.