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Isis Pharmaceuticals Reports Clinical Data Showing Blunting of Severe Increases in CRP Following Endotoxin Challenge With ISIS-CRP Rx
Date:3/13/2013

CARLSBAD, Calif., March 13, 2013 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that ISIS-CRPRx selectively reduced severe elevations in C-reactive protein (CRP) in humans.  Data from a Phase 1 clinical study showed that ISIS-CRPRx produced statistically significant, dose-dependent reductions in CRP response following an endotoxin challenge, which produces immune responses similar to those seen with bacterial infections.  In this study, significant reduction of the endotoxin-induced CRP response was achieved in the healthy volunteers treated with ISIS-CRPRx, with no changes in other important immune modulators, such as TNF-alpha, IL-6, and other cytokines and chemokines.  Selective reduction of CRP could offer a safer approach to treating patients who have chronic inflammatory diseases, such as rheumatoid arthritis, by potentially lowering the risk of infections, a common side effect of other anti-inflammatory drugs, such as TNF-alpha inhibitors.  A Phase 2 study of ISIS-CRPRx in patients with rheumatoid arthritis is currently underway with data anticipated in the middle of this year.

"The study illustrates the considerable specificity of antisense technology to target a single component of a complex immunologic response," said Dr. Paul Ridker of the Brigham and Women's Hospital and the Harvard Medical School.  "Thus, the approach shown to be effective here provides an opportunity to evaluate the role of CRP in different inflammatory disorders."

"This study is the first clinical demonstration of selective blunting of severe increases in CRP.  The fact that reductions in CRP can be achieved without affecting any other key inflammatory markers supports a potentially valuable profile for CRP inhibition in infla
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SOURCE Isis Pharmaceuticals, Inc.
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