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Genzyme, Isis report mipomersen data

August 5, 2010 12:29 AM UTC

Genzyme Corp. (NASDAQ:GENZ) and partner Isis Pharmaceuticals Inc. (NASDAQ:ISIS) said two Phase III trials of mipomersen to treat hypercholesterolemia met their respective primary endpoints. In 158 patients with hypercholesterolemia and a high risk of developing coronary heart disease (CHD), mipomersen produced significantly greater reductions in LDL-C from baseline to week 28 vs. placebo (37% vs. 5%, p<0.001). In 58 patients with severe hypercholesterolemia, mipomersen significantly reduced LDL-C by 36% from baseline to week 28 vs. a 13% increase for placebo (p<0.001).

Genzyme and Isis said a total of 34 of the 144 patients receiving mipomersen in the trials discontinued treatment due to adverse events, including elevations in liver alanine transaminase (ALT) levels, injection-site reactions and flu-like symptoms. Specifically, 10% of mipomersen patients in the first trial and 15% in the second trial had persistent ALT levels that were above three times the upper limit of normal. The partners said the nature of the AEs were "generally similar" to what was seen in earlier trials. ...