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[posting]38920175[/posting]http://www.thestreet.com/story/10678655/1/isis-genzyme-fall-… (...) On a conference call Wednesday morning, Isis CEO Stanley Crooke downplayed the mipomersen safety worries, stating that "no new concerns" were raised in this study that were not detected in previous studies. Furthermore, Crooke said none of the patients treated with mipomersen experienced liver dysfunction. Yet, at the same time, Crooke, in reply to a question, conceded that MRI scans of mipomersen patients in the study detected fat deposits on their livers -- a safety signal that wasn't found in prior mipomersen studies. "We're still analyzing the data," said Crooke of the liver-fat findings, adding that it's consistent with what's been shown when mipomersen was tested in animals. Isis and Genzyme previously conducted a phase III study of mipomersen in patients with homozygous familial hypercholesterolemia (HoFH) -- a rarer and much more severe form of the same disease in which patients inherit two defective genes that can cause fatal levels of cholesterol elevation. In that study, mipomersen lowered cholesterol levels by 25% but patients also experienced elevated liver enzymes. HeFH patients are less sick than HoFH patients, so expectations going into Wednesday results were that mipomersen would cause less liver toxicity in HeFH patients. But in its announcement Wednesday and on the conference call, Isis described the liver safety data as being "similar" between the two patient groups. (...) |
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| aus der Diskussion: | Biotech Depot 2010 |
| Autor (Datum des Eintrages): | PathFinder2 (10.02.10 18:04:59) |
| Beitrag: | 133 von 334 (ID:38920324) |
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