Pharmaprojects R&D Pipeline News Feed
Ark refiles gene therapy treatment in the EU
8 Dec 2008
UK company Ark Therapeutics has refiled its novel gene therapy Cerepro in the EU. Cerepro was originally filed for approval in 2005, based on Phase II trial results; however, the CHMP recommended against approval due to the low numbers of patients enrolled as well as concerns with trial methodology. Ark has based the refiling on Phase III results in 236 brain cancer patients which showed that those receiving Cerepro experienced a 42 day benefit in time to death or intervention following tumour recurrence.
Cerepro uses the adenoviral vector Ad5 to introduce the herpes simplex virus thymidine kinase gene to cells around the tumour site following resection. This is followed by administration of the antiviral ganciclovir which is phosphorylated by the modified cells into a highly cytotoxic triphosphate compound, intended to target any cells attempting to undergo mitosis such as cancerous cells. This spares helathy brain cells which do not usually undergo cell division.
Ark also intends to discuss a US filing with the FDA, though this may require further trials and no date for this has been set.
