Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced the initiation of a Phase 1 study of ISIS-FXIRx, an antisense drug designed to treat clotting disorders. ISIS-FXIRx inhibits the production of Factor XI, a clotting factor that is an important component of the coagulation pathway. Because of its role in the intrinsic coagulation pathway, inhibition of Factor XI could offer an effective approach for preventing the formation of blood clots with a lower risk of bleeding.
"High levels of Factor XI are a risk factor for aberrant blood clot formation. Blood clot formation is a leading cause of morbidity and mortality associated with vascular diseases, including heart attack, deep vein thrombosis and stroke. Blood clot formation is also a common complication of surgical procedures, especially orthopedic surgeries such as knee or hip replacement. Most commonly used therapies reduce clotting, but also produce an unacceptable increase in bleeding risk," said Brett Monia, Ph.D., Vice President, Drug Discovery and Corporate Development of Isis. "In preclinical studies, ISIS-FXIRx demonstrated potent antithrombotic activity with no increase in bleeding compared with standard anti-clotting agents, including low-molecular weight heparin, warfarin and Factor Xa inhibitors, all of which increased bleeding. Furthermore, humans who are deficient in Factor XI have a lower incidence of thromboembolic events with minimal increase in bleeding risk, providing human genetic validation of this target."
"We have a growing cardiovascular franchise. ISIS-FXIRx broadens our therapeutic approaches in cardiovascular disease beyond lipid management to include anti-thrombotics. The broad applicability of our antisense technology has allowed us to build a pipeline of drugs to improve numerous aspects of cardiovascular disease," said Richard Geary, Ph.D., Senior Vice President, Development of Isis.
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