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Rigel Reports Progress in Drug Development Programs
SOUTH SAN FRANCISCO, CA, - October 07, 2002
October 7, 2002 – Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is making good progress in advancing all three of its lead drug development programs and is on track to have three drugs in clinical testing by the end of 2003, the company told investors today at the UBS Warburg Global Life Sciences Conference.
Rigel said that the phase I safety trial for its first product, a drug for allergic rhinitis, has been completed. The study, which began last month in the United Kingdom, found no untoward reactions to the drug. These data will now be incorporated into an Investigational New Drug (IND) application that the company plans to file with the U.S. Food and Drug Administration before the end of this year. Clinical testing in the United States is scheduled to begin shortly thereafter at National Jewish Hospital in Denver.
“Dosing in the U.K. study was uneventful and sets the stage to move rapidly into initial phase II studies in the United States,” James Gower, Rigel’s chairman and chief executive officer, told the conference. “For this, we’re pleased to have enlisted the participation of National Jewish, one of the country’s premier institutions for the treatment of allergic diseases.”
The drug now in the clinic, R112, is the first of a new class of drug that works against mast cells, a type of immune blood cell. Mast cells, when activated by exposure to an allergen, play a key role in initiating the inflammatory response in allergy and asthma. Rigel anticipates that R112 would be used to treat serious, chronic allergic nasal congestion, which is now most often treated with inhaled steroids. Building on its lead in drugs directed at mast cells, Rigel is also advancing a related compound for the treatment of asthma. The company plans to move this second product into clinical testing by the end of 2003.
“We believe that we can execute both clinical mast cell programs very efficiently,” Mr. Gower noted. “In the case of allergic rhinitis, the research protocols and endpoints are well defined and the duration of follow up is brief. For asthma, we’ve chosen to develop the drug for inhalation rather than systemic administration. This should enable us to move more quickly through clinical testing in a population of patients who are already very accustomed to using inhaled drugs.”
Targeting Other Large Markets
Mr. Gower also outlined Rigel’s aggressive drug discovery and development programs in the fields of hepatitis C and oncology. As Mr. Gower explained, these indications meet Rigel’s goal of creating drugs to address large segments of the medical market that have significant unmet therapeutic needs.
For hepatitis C, Rigel has identified a novel type of drug that, in initial studies, appears to block viral replication. This is significant because drugs currently on the market do not target the hepatitis C virus (HCV) itself but rather work to boost the immune system, often resulting in suboptimal treatment. A drug that directly attacks the virus could significantly improve treatment for the nearly 150 million people worldwide who are chronically infected with HCV. Rigel is nearing the completion of preclinical evaluation for its hepatitis compound and plans to begin clinical testing in mid-2003.
Rigel’s third lead drug development program focuses on a new type of cancer target called ligases. These are enzymes that mediate the degradation of proteins, which in turn affects many important cellular functions, including cell division. In the past few years, ligases have become the subject of intense interest among oncology drug researchers. Rigel has made a major commitment to this field, with an extensive research and development program that the company expects will begin producing clinical candidates in 2004 and beyond.
“We believe that our hepatitis C and ligase programs are true industry leaders,” Mr. Gower noted. “In hepatitis, we are right in there among companies racing to move the next wave of drugs into the clinic. In ligases, we believe our efforts are ahead of just about everyone, giving us not only an R&D advantage but also the opportunity to build an intellectual property portfolio that will help solidify our lead as this field takes off.”
Mr. Gower stressed that all of Rigel’s lead drug candidates come entirely from internal discovery and development efforts. This success in drug creation comes, first, from Rigel’s agile, proprietary technology that enables the company to home in on critical parts of the disease pathway that are likely to make good drug targets. In addition, Rigel has assembled the medicinal chemistry, high throughput compound screening and clinical infrastructure that the company believes will enable it to turn these leads into compelling pharmaceutical candidates.
“The result is sustainable drug discovery and the creation of novel drugs that we own completely,” Mr. Gower concluded. “We believe this is a recipe for success.”
About Rigel (www.rigel.com)
Rigel’s mission is to become a source of novel, small-molecule drugs to meet large, unmet medical needs. The company’s business model is to develop a portfolio of drug candidates and to take these through phase II clinical trials, after which Rigel intends to seek commercialization partners for completion of clinical evaluation, regulatory approval and marketing. Rigel has identified three areas for its lead product research programs: mast cell activation to treat asthma/allergy, an antiviral agent to treat hepatitis C and ubiquitin ligases for cancer. Rigel has begun clinical testing of its first product, for allergic rhinitis, and plans to follow that with two additional drugs in the clinic by the end of 2003. Rigel’s approach to drug discovery is based on advanced, proprietary functional genomics techniques that allow the company to identify targets with a demonstrable role in a disease pathway and to efficiently screen for those that are likely to be amenable to drug modulation.
This press release contains "forward-looking" statements, including statements related to Rigel’s business strategy, drug development programs and clinical trial plans. 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 “believes,” “anticipates,” “plans,” “intends,” “expects,” “will” and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause our results to differ materially from those indicated by these forward-looking statements, including the risks detailed from time to time in Rigel’s SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2001. Rigel does not undertake any obligation to update forward-looking statements.
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