Genzyme: Phase III mipomersen a success

Researchers for Genzyme and Isis Pharmaceuticals say that a late-stage clinical trial turned up positive data for their cholesterol drug mipomersen. Patients taking the drug over a 26-week period reported a 25 percent drop in bad LDL. Only three percent of the patients in the control arm had a similar experience. Side effects of the drug included flu-like symptoms and elevations in liver transaminases. Of the 34 patients treated with mipomersen, 28 completed the study. One patient discontinued due to elevations in liver transaminases.

"These are promising results for a very high-risk patient population that is in great need of new treatment options," said Genzyme CMO Richard A. Moscicki, M.D. "This is one of the largest studies of hoFH patients ever conducted, and we are very encouraged by these robust data and the emerging profile of the drug. With these results, we remain on-track with our development plan for mipomersen." Genzyme says that it is on track to file for an approval in the second half of 2010.

- see the release
- here's the report