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Safety signal dampens reception for mipomersen antisense

Safety signal dampens reception for mipomersen antisense n E ws In this section Herceptin’s easy- Pharmacy provid- Discord over new to-use formulation ers push for gene biofuel life-cycle p298 tests p299 figures p304 In February, Isis announced its cholesterol- lowering antisense therapy, mipomersen, had met its endpoints in a phase 3 trial of 124 patients with heterozygous familial hyper- cholesterolemia (FH) and coronary artery disease. The news ought to have sent share prices soaring, as mipomersen, if approved, could rival blockbuster statin drugs. Instead, lingering concerns related to high liver enzyme levels in some trial participants—a safety signal that had been noted in previous trials—dampened investor enthusiasm. But even if elevated liver enzymes make it less likely that mipomersen will supplant statins in major indications like coronary artery dis- ease, efficacy data for the antisense therapy in patients with homozygous FH remain compelling. The latest trial results provide valida- tion that antisense drugs do have sufficient potency to rival traditional small-molecule drugs. After the clinical and regulatory dis- Mipomersen has the potential to challenge statins’ market dominance, but reports of liver toxicity are appointments of antisense therapy’s other causing concern. poster child, Genasense (oblimersen), Alan Gewirtz, an antisense researcher at the University of Pennsylvania School of http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Nature Biotechnology Springer Journals

Safety signal dampens reception for mipomersen antisense

Kling, Jim
Nature Biotechnology , Volume 28 (4) – Apr 1, 2010
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References (2)

Publisher
Springer Journals
Copyright
Copyright © 2010 by Nature Publishing Group
Subject
Life Sciences; Life Sciences, general; Biotechnology; Biomedicine, general; Agriculture; Biomedical Engineering/Biotechnology; Bioinformatics
ISSN
1087-0156
eISSN
1546-1696
DOI
10.1038/nbt0410-295
Publisher site
See Article on Publisher Site

Abstract

n E ws In this section Herceptin’s easy- Pharmacy provid- Discord over new to-use formulation ers push for gene biofuel life-cycle p298 tests p299 figures p304 In February, Isis announced its cholesterol- lowering antisense therapy, mipomersen, had met its endpoints in a phase 3 trial of 124 patients with heterozygous familial hyper- cholesterolemia (FH) and coronary artery disease. The news ought to have sent share prices soaring, as mipomersen, if approved, could rival blockbuster statin drugs. Instead, lingering concerns related to high liver enzyme levels in some trial participants—a safety signal that had been noted in previous trials—dampened investor enthusiasm. But even if elevated liver enzymes make it less likely that mipomersen will supplant statins in major indications like coronary artery dis- ease, efficacy data for the antisense therapy in patients with homozygous FH remain compelling. The latest trial results provide valida- tion that antisense drugs do have sufficient potency to rival traditional small-molecule drugs. After the clinical and regulatory dis- Mipomersen has the potential to challenge statins’ market dominance, but reports of liver toxicity are appointments of antisense therapy’s other causing concern. poster child, Genasense (oblimersen), Alan Gewirtz, an antisense researcher at the University of Pennsylvania School of

Journal

Nature Biotechnology – Springer Journals

Published: Apr 1, 2010

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