( for a few days viaapheresis is an his...)Isis Pharmaceuticals Reports Positive Phase 2 Data for ISIS 301012,in Familial Hypercholesterolemia Patients Presented at ACC,Health

for a few days via apheresis, is an historic milestone in the therapy for this deadly disease. Lowering Lp(a), another cardiovascular risk factor, by 30 to 70% is another first, and may also prove to be quite valuable. Importantly, HDL-C and apoA-1, which are low in these patients, either remained stable or increased. Based on these data, along with the tolerability and acceptance of ISIS 301012 by the patients, I am extremely encouraged about its potential to have a really meaningful impact on the course of this devastating disease."

Mark Wedel, M.D., J.D., Isis' Chief Medical Officer, added, "We're delighted with the significant lipid-lowering activity of ISIS 301012, especially in this patient population that is typically less responsive to statin therapy. We are also very encouraged that ISIS 301012 was so well tolerated, especially in these severely hypercholesterolemic patients, in the background of high-dose statin therapy and combined with ezetimibe. We are looking forward to continued follow-up, and to finalizing our registration plans for this desperate-need population with the FDA in the near future."

In the study, three HoFH patients on stable maximally-tolerated lipid- lowering therapies of 80 mg atorvastatin, 80 mg atorvastatin plus ezetimibe, colesevelam, and niacin, or 40 mg rosuvastatin plus ezetimibe with respective baseline LDL-C levels of 651 mg/dL, 197 mg/dL, and 445 mg/dL, were treated with ISIS 301012 at a dose of 300 mg/week. At the time the data were analyzed for the presentation, the patients had been dosed for 12 weeks, 11 weeks and 6 weeks, respectively, and their LDL-C levels were 328 mg/dL (50% reduction), 91 mg/dL (54% reduction), and 301 mg/dL (32% reduction). The subjects continue in dosing and follow-up. The data are summarized in tabular form below. Because HoFH is an extremely rare condition affecting one person per million, clinical trials in this disease are generally quite small, and because it is such a serious d
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