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Rigel Announces Initiation of Clinical Trials in Two Immunology Programs
Date:1/5/2012

ating other immune system disorders. Phase 1 clinical studies in normal healthy volunteers began in the fourth quarter of 2011.

R333, Topical JAK/SYK Inhibitor

Discoid Lupus Erythematosus (DLE) is an autoimmune system disorder of the skin. Inflamed disk-shaped sores on the face, chest and scalp, which may result in scaring, swelling and hair loss, characterize DLE. This disorder has an acute phase, which research has connected to SYK kinase signaling within the immune cascade. There is also a chronic phase of the disorder due to the abundance of JAK signaling. The current treatment options available for discoid lupus are few and have toxicities that further limit their use. In December 2011, Rigel began a Phase 1 clinical trial of R333, a topical JAK/SYK inhibitor, which may be useful in treating both phases of this potentially disfiguring disorder.  

R343, Inhaled SYK Inhibitor

In addition to the above clinical programs, Rigel expects to initiate a Phase 2 trial with R343, an inhaled SYK inhibitor, for patients with allergic asthma in mid-2012. This multi-center, multiple dose, placebo controlled study is expected to include approximately 300 asthma patients.  R343 will be delivered directly into the lungs via a dry inhalation device. Rigel will share additional information about its plans for R343 in future announcements.

Fostamatinib, SYK Inhibitor

In the meantime, Rigel's collaborator on fostamatinib, AstraZeneca (AZ), has indicated that the Phase 3 studies in rheumatoid arthritis are continuing as planned. The first of the OSKIRA (Oral SYK Inhibition in Rheumatoid Arthritis) studies, OSKIRA-1, completed full enrollment in the fourth quarter of 2011. OSKIRA-1 is a 12-month clinical trial of approximately 900 patients studying two dosing regimens of fostamatinib compared to placebo in patients who are not achieving an ad
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SOURCE Rigel Pharmaceuticals, Inc.
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