Press Releases
Isis Pharmaceuticals Reports Data From a Phase 2 Study of Isis-CRP Rx in Patients With Rheumatoid Arthritis
"CRP is strongly associated with the presence and severity of many diseases, including numerous inflammatory and cardiovascular diseases. In this study, by treating patients with chronically elevated CRP with ISIS-CRPRx, we hoped to accomplish three things: to confirm in patients the substantial CRP-lowering activity we observed in our earlier clinical studies, to gain additional experience with the drug before testing it in more severe indications, and to evaluate whether lowering CRP correlates with an improvement in RA symptoms. The study accomplished its goals. We are pleased with the consistency of CRP lowering across all of our clinical studies, but we are disappointed that we did not see a greater impact on RA symptoms in these patients," said
The Phase 2 study was a randomized, placebo-controlled, multiple-dose study in patients with RA who had chronically elevated CRP. In this study, 51 patients received 100 mg, 200 mg or 400 mg dose of ISIS-CRPRx or placebo for 12 weeks. Patients in the study treated with ISIS-CRPRx achieved substantial, dose-dependent reductions in CRP early in treatment that were prolonged through the treatment process. Patients also experienced improvements in the signs and symptoms of RA, as measured by ACR20 and ACR50 scores. These improvements correlated with reductions in CRP, but were not sufficiently greater than improvements observed in the placebo groups to justify further development of ISIS-CRPRx for RA.
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Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer. Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO™, in
ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the development, activity, therapeutic potential and safety of ISIS-CRPRx. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs, including the commercial potential of KYNAMRO, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended
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SOURCE
Executive Director, Corporate Communications and Investor Relations, 760-603-2741, or Amy Blackley, Ph.D., Associate Director, Corporate Communications, 760-603-2772