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Isis Initiates Phase 2 Study Of ISIS-FXIRX In Patients Undergoing Knee Replacement Surgery
Date:10/29/2012

CARLSBAD, Calif., Oct. 29, 2012 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 2 comparator-controlled study evaluating ISIS-FXIRx in patients undergoing knee replacement surgery, also referred to as total knee arthroplasty (TKA).  ISIS-FXIRx inhibits the production of Factor XI, a coagulation factor produced in the liver that is involved in the formation of clots.  In this study, Isis will evaluate the effectiveness of ISIS-FXIRx in reducing the number of thrombotic events in patients after TKA without increasing bleeding.  The combination of robust anti-thrombotic activity with an improved safety profile to currently available anticoagulants could be broadly useful in many therapeutic settings where thrombosis is a serious problem.

"Although there are a number of anti-coagulants on the market today that are considered standard-of-care in multiple therapeutic settings, complications of bleeding associated with these medications remain high and can lead to fatal outcomes," said Harry Buller, Ph.D., M.D., professor of medicine at Academic Medical Center in Netherlands.  "Factor XI is an exciting target because it plays a key role in the formation of clots but inhibiting it does not cause bleeding.  Humans who are deficient in Factor XI tend to have a lower incidence of stroke and venous thrombosis with no evidence of spontaneous bleeding episodes."

The Phase 2 study is a global, multi-center, open-label, comparator-controlled study in up to 400 patients who are undergoing TKA.  The study will compare ISIS-FXIRx safety and activity to enoxaparin, a commonly used anti-coagulant.  In a Phase 1 study in healthy volunteers, ISIS-FXIRx produced robust dose-dependent, statistically significant reduction of greater than 80 percent in Factor XI
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SOURCE Isis Pharmaceuticals, Inc.
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