Access
To read this article in full you may need to log in, make a payment or gain access through a site license (see right).
News
Nature Biotechnology 26, 1057–1059 (1 October 2008) | doi:10.1038/nbt1008-1057
Ark floats gene therapy's boat, for now
Abstract
In August, gene therapy's turbulent ride through the clinical rapids took a new twist as Ark Therapeutics released positive top-line results from a phase 3 trial of its adenoviral gene therapy Cerepro (sitimagene ceradenovec) for malignant brain tumors. Although the news boosted the London-based firm's shares, the course to market authorization and registration remains strewn with uncertainty—as Introgen, of Austin, Texas, found, to its cost, when the US Food and Drug Administration (FDA) recently refused its Biologics License Application (BLA) for Advexin (contusugene ladenovec), an orphan-designated adenoviral gene therapy for treating head and neck cancer and Li-Fraumeni syndrome.
To read this article in full you may need to log in, make a payment or gain access through a site license (see right).
