SOUTH SAN FRANCISCO, Calif., Dec. 20 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. today announced that it has advanced the clinical development programs for R788, an orally available product candidate for the treatment of inflammatory diseases, and R763, an orally available multi-Aurora kinase inhibitor being developed to treat cancer. The company has initiated a Phase I double-blind, placebo controlled trial to investigate the safety and pharmacokinetics of R788 in combination with methotrexate in rheumatoid arthritis patients. Methotrexate is a commonly used treatment for rheumatoid arthritis (RA). Rigel also announced that it has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for R763.
"Our clinical and research programs continue to progress and we remain committed to our goal of initiating clinical trials with at least one new product candidate each year," said James M. Gower, chairman and chief executive officer of Rigel. "In 2006, we look forward to initiating efficacy studies of R788 in rheumatoid arthritis, as well as proceeding with R763 in cancer development."
R788 is a novel, oral syk kinase inhibitor that blocks the activation of mast cells, macrophages and B cells that promote swelling and an inflammatory response. It is being developed initially to treat rheumatoid arthritis, a chronic inflammatory disease that affects nearly 2.1 million people in the United States. RA is often progressive and debilitating, preventing people from living a symptom-free life. Phase I trial results, completed to date, have demonstrated that R788 is well-tolerated and showed good pharmaceutical properties. In preclinical studies, Rigel's compound greatly diminished the swelling and tissue destruction associated with RA. The study, done in combination with methotrexate, will evaluate 16 patients from the United States who have stable disease. Rigel plans to begin efficacy studies of R788 in 2006.
R763 is being developed as part of an Aurora kinase collaboration with Serono. Serono is responsible for the further development and commercialization of R763, as well as any other product candidates arising from Rigel's Aurora kinase inhibitor program. R763 has been shown in in vitro and in vivo tumor xenograft models to inhibit proliferation and trigger apoptosis in several tumor cell lines including the cervix, colon, lung, pancreas, and prostate.
About Rigel (www.rigel.com)
Rigel is a clinical-stage drug development company that discovers and develops novel, small-molecule drugs for the treatment of inflammatory diseases, cancer and viral diseases. Our goal is to move one new product candidate for a significant indication into the clinic each year. We have achieved this goal since 2002. Our 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 our product candidates. We have product development programs in allergy/asthma, rheumatoid arthritis and cancer.
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.
Contact: Raul Rodriguez Phone: 650.624.1302 Email: invrel@rigel.com Media Contact: Carolyn Bumgardner Wang, WeissComm Partners, Inc. Phone: 415.946.1065 Email: carolyn@weisscommpartners.com
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20030226/RIGLLOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk photodesk@prnewswire.comRigel Pharmaceuticals, Inc.CONTACT: Raul Rodriguez of Rigel Pharmaceuticals, Inc., +1-650-624-1302,or invrel@rigel.com; or Carolyn Bumgardner Wang of WeissComm Partners,Inc., +1-415-946-1065, or carolyn@weisscommpartners.com, for RigelPharmaceuticals, Inc.
Web site: http://www.rigel.com/
