press release archive
Current | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997
Rigel Announces Initiation of Phase II Study Evaluating R788 in Rheumatoid Arthritis
SOUTH SAN FRANCISCO, Calif. - September 06, 2006
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced today that it has initiated enrollment and dosing in a Phase II study evaluating the efficacy and safety of its lead product candidate, R788, an oral syk kinase inhibitor, for the treatment of patients with rheumatoid arthritis (RA).
"As an oral agent with the potential to modify the course of RA, R788 is a very attractive product candidate for the treatment of this disease," said Elliott B. Grossbard, M.D., senior vice president of medical development of Rigel. "We are hopeful that we will see clinical efficacy for R788 in this Phase II trial."
This multi-center, randomized, double-blind, placebo-controlled, ascending dose, dose ranging study will evaluate up to three doses of R788. The study is expected to enroll approximately 180 patients in the U.S. who have had RA for a minimum of 12 months and who have active disease despite receiving adequate doses of methotrexate.
The primary endpoint of this study is to determine the percent of ACR 20 responders at the end of 12 weeks. An ACR 20 response requires at least a 20% improvement in a number of different measures of disease activity, and is one of the standard measures to assess efficacy in RA clinical trials. Secondary endpoints include other measures of disease activity as well as safety.
Rheumatoid Arthritis: Current Treatments and Market Opportunity
The current treatment options for RA have potentially significant shortcomings and/or side effects. Some RA patients currently receive multiple drugs depending on the extent and aggressiveness of the disease. Most RA patients require some form of DMARD— including methotrexate, an anti-cancer agent, or TNF-blocking agents such as Enbrel®. The TNF-blocking agents only inhibit the inflammatory mediator TNF, and are all delivered via injection. Rigel believes that there is a significant opportunity for an oral DMARD that can be used earlier in the course of the disease, preventing its progression prior to major bone and cartilage destruction; this is the product goal for R788 in RA.
About Rigel (www.rigel.com)
This press release contains "forward-looking" statements, including statements related to Rigel's plans with respect to clinical development of product candidates, the market opportunity for its product candidates, and expansion of its product portfolio. 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," “promising,” "expects," “anticipates” 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 clinical trials and the commercialization of product candidates, as well as other risks detailed from time to time in Rigel's SEC reports, including its Form 10-Q for the quarter ended June 30, 2006. Rigel does not undertake any obligation to update forward-looking statements.
Contact: Raul Rodriguez
Media Contact: Carolyn Bumgardner Wang, WeissComm Partners, Inc.