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July 17, 2014
07:10 EDTISISIsis Pharmaceuticals begins Phase 2 study of candidate for high lipoprotein(a)
Isis Pharmaceuticals initiated a Phase 2 study evaluating ISIS-APO(a)Rx in patients with high lipoprotein(a), or Lp(a), an independent risk factor for cardiovascular disease. Isis plans to develop ISIS-APO(a)Rx to treat patients with high Lp(a) levels who are at high risk of experiencing life-threatening cardiovascular events. The Phase 2 study is a randomized, placebo-controlled, dose-titration study evaluating the safety and efficacy of ISIS-APO(a)Rx. The 12 week study will evaluate 100 mg, 200 mg and 300 mg doses of ISIS-APO(a)Rx in approximately 60 patients with Lp(a) levels of 50 mg/dL or greater.
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July 6, 2015
07:05 EDTISISAkcea Therapeutica receives orphan drug designatoin from FDA for Volanesorsen
Akcea Therapeutics, a wholly-owned subsidiary of Isis Pharmaceuticals, announced that the FDA has granted Orphan Drug Designation to volanesorsen for the treatment of patients with Familial Chylomicronemia Syndrome. FCS is a rare genetic disease characterized by extremely high triglyceride levels and risk of pancreatitis. In a Phase 2 study published in the NEJM in December 2014, patients with FCS treated with volanesorsen achieved substantial reductions in apoC-III, triglycerides, chylomicrons and apoC-III-associated very low density lipoprotein-cholesterol particles.1 Akcea is currently conducting an international multi-center, randomized, double-blind, placebo-controlled Phase 3 study in patients with FCS.
June 23, 2015
18:04 EDTISISIsis Pharma granted FDA orphan status for treatment of familial chylomicronemia
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08:58 EDTISISIsis Pharmaceuticals shares not reflecting SMA data, says Needham
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June 22, 2015
07:01 EDTISISIsis Pharmaceuticals reports data from ISIS-SMN Rx in Phase 2 study
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