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Isis Pharmaceuticals Updates Its Positive Phase 2 Data for ISIS,301012 in Familial Hypercholesterolemia Patients

* Treatment with ISIS 301012 produced at least 45% additional reduction in patients' LDL-cholesterol when added to maximally-tolerated lipid-lowering therapies

CARLSBAD, Calif., May 17, 2007 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. announced updated results from its ongoing Phase 2 clinical trial of ISIS 301012 in patients with homozygous familial hypercholesterolemia (HoFH), initial results of which were presented in March at the of Cardiology Annual Scientific Session (ACC) in New Orleans. The three HoFH patients dosed with 300 mg/week of ISIS 301012 for twelve weeks have now completed treatment. With ISIS 301012, the patients achieved 45%, 50% and 51% additional reductions in LDL-cholesterol beyond that achieved with maximally-tolerated lipid-lowering therapy, with similar reductions in apoB of 45%, 43% and 54%. ISIS 301012 continued to be well tolerated in the study.

"The magnitude of LDL-cholesterol response in these three HoFH patients has surpassed anything I have seen in the last 30 years, including with statins," stated Evan Stein, M.D., Ph.D., Director, Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio, lead investigator in the study. "It offers for the first time the potential for good, life-long control of LDL without expensive and invasive therapies such as apheresis, liver transplantation and other heroic measures we have tried over the years."

ISIS 301012 has been granted orphan drug status for the treatment of homozygous FH, one of the most severe forms of hypercholesterolemia and one that is highly resistant to treatment. Patients with this genetic condition typically suffer heart attacks at an early age. Isis plans to begin registration-directed studies for FH in 2007.

ISIS 301012 in Homozygous Familial Hypercholesterolemia

The data presented are part of a single-arm, open-label, dose-escalation study. Because the study was designed princip
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