Isis has been on a good-news roll lately, and today is no exception. The company announced positive results from a Phase II open-label extension trial of of ISIS 301012, a cholesterol-lowering drug for with familial hypercholesterolemia. The study included 16 patients who had participated in an earlier Phase II study of the drug. These patients received weekly doses of ISIS 301012 for as long as six months and didn't experience any new or worsening adverse events.
"We are particularly pleased to have had such an uneventful experience with patients in the long-term study. Until now, the longest exposures to ISIS 301012 had been three months, and now to have patients dosed for a total of more than six months without any tolerability issues is quite reassuring," stated John J.P. Kastelein, M.D., Ph.D., a principal investigator for the studies. "Of course, we will all be eager to see more patients and longer exposure times to strengthen our confidence that ISIS 301012 could truly be a transformational new drug for the treatment of refractory high cholesterol."
- see the release from Isis for more
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