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Rigel Announces Disappointing Results from Phase II Study of R112 for the Treatment of Allergic Rhinitis
SOUTH SAN FRANCISCO, Calif. - December 01, 2005
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced results from a comparative Phase II clinical study of R112, a potential intranasal therapy for the treatment of allergic rhinitis. The randomized, double-blind study compared R112 and Beconase AQ® (beclomethasone) nasal spray to placebo, over a 7-day period. In the trial, treatment with R112 failed to show a statistically significant difference from placebo treatment in improving nasal allergy symptoms, the study’s primary endpoint. Beconase AQ was superior to placebo treatment. Rigel will host a conference call today at 4:30 p.m. Eastern to discuss these results (see below for conference call details).
“We are disappointed in today’s results,” said James M. Gower, chairman and chief executive officer of Rigel. “These results are surprising given that the earlier Phase II ‘Park’ study of R112 demonstrated a statistically significant reduction in the symptoms associated with allergies.”
Study Details and Prior Phase II Results
In an earlier Phase II “Park Study” clinical trial, R112 demonstrated statistically significant efficacy in improving symptoms of allergic rhinitis, including sneezing, stuffy nose, running nose, itchy nose, itchy throat, post nasal drip, cough, headache and facial pain, and had a rapid onset of action as early as 30-45 minutes over a two day period. In all clinical studies to date, R112 has been shown to have a favorable safety profile.
Allergic Rhinitis: Role of Immune Mediators and Current Treatments
Common allergy drugs such as antihistamines or antileukotrienes block only a single mediator. Intranasal steroids are able to block multiple mediators in the allergic response, but these can have a slow onset of action and sometimes require multiple days of treatment before a positive effect is seen. Despite the drawbacks of these treatments, the U.S. market for allergic rhinitis therapies approaches $4 billion.¹
Conference Call Details
About Rigel (www.rigel.com)
This press release contains "forward-looking" statements, including statements related to Rigel's plans to pursue clinical development of product candidates and the timing thereof and the potential efficacy of 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 "plans," "intends," "expects" and similar expressions are intended to identify these forward-looking statements. 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 risks associated with the timing and success of pre-clinical studies and clinical trials, as well as other risks detailed from time to time in Rigel's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2005. Rigel does not undertake any obligation to update forward-looking statements.
Beconase AQ is a registered trademark of GlaxoSmithKline.
¹Decision Resources, Inc.
Contact: Raul Rodriguez
Media Contact: Carolyn Bumgardner Wang, WeissComm Partners, Inc.