|Rigel Announces Initiation of Clinical Trials in Two Immunology Programs|
|Robust Pipeline will be the Company's focus at J.P. Morgan Conference
"Rigel continues to be one of the most productive companies in the biopharmaceutical sector, as evidenced by the commencement of First in Human (FIH) studies in two programs this past quarter," said
R548, JAK3 Inhibitor
Transplant rejection is an area of tremendous medical need. While 90% of patients survive the first year after receiving the transplanted organ, chronic organ rejection rates rise to 50% within the five to ten years following surgery. Currently available therapeutics are not sufficient to help these patients achieve lasting recovery. Furthermore, transplants of certain organs are rarely done because of the inadequacies of these therapies. Rigel's R548 is a JAK3 inhibitor that is expected to moderate the immune system's response to the allograft and improve patient outcomes. R548 may also have application in treating 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
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,
To access the live audio webcast of the company presentation at the
About Rigel (http://www.rigel.com/)
Rigel is a clinical-stage drug development company that discovers and develops novel, small-molecule drugs for the treatment of inflammatory and autoimmune diseases, as well as muscle disorders. Rigel's pioneering research focuses on intracellular signaling pathways and related targets that are critical to disease mechanisms. Rigel's productivity has resulted in strategic collaborations with large pharmaceutical partners to develop and market its product candidates. Current product development programs include fostamatinib, an oral SYK inhibitor that is in Phase 3 clinical trials for rheumatoid arthritis, R343, an inhaled SYK inhibitor that has completed Phase 1 clinical trials for asthma, R548, an oral JAK3 inhibitor for the treatment of transplant rejection and other immune disorders, and R333, a topical JAK/SYK inhibitor for the treatment of discoid lupus.
This press release contains "forward-looking" statements, including, without limitation, statements related to Rigel's future product candidate pipeline and strategy, the potential uses and efficacy of Rigel's product candidates, the timing and design of its future clinical trials and potential milestones and regulatory filings associated with Rigel's product candidates. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "will," "may," "aim," "believe," "plan," "expect," "potential," and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based upon Rigel's current expectations and involve risks and uncertainties. There are a number of important factors that could cause Rigel's results to differ materially from those indicated by these forward-looking statements, including, without limitation, risks associated with Rigel's need for additional capital, the timing and success of preclinical studies and clinical trials and the potential problems that may arise in the research and development and approval process, market competition, risks associated with Rigel's corporate partnerships, including risks that if conflicts arise between Rigel's and its corporate partners, the clinical development or commercialization of the affected product candidates or research programs could be delayed or terminated, as well as other risks detailed from time to time in Rigel's reports with the