UK biotechnology group Ark Therapeutics has pulled back the European marketing application for its brain cancer drug Cerepro, which it hopes will become the world’s first gene-therapy based product to hit the market.
The company first submitted its application for Cerepro (adenovirus-mediated Herpes simplex virus-thymidine kinase gene) for the treatment of patients with operable high-grade glioma to the European Medicines Agency in October 2005, but in April 2006 the Committee for Medicinal Products for Human Use gave it the thumbs down.
In a statement accompanying its financial results earlier this year, the company claimed it spent 2006 responding to the CHMP’s questions about the drug, which were not surprising given the “many hitherto undefined regulatory and manufacturing requirements…of this new and exciting class of medicines.”
Filing next year
Ark had also requested a re-examination of the CHMP’s negative opinion, which had not yet finished when the group decided to withdraw its marketing application but has since concluded with no change to the original verdict.
In a letter to European regulators explaining the temporary withdrawal, the group said that the results of a multicentre study of the drug’s safety and efficacy, which are required for approval, will not be available until next year. But in a statement, the company confirmed that progress with Cerepro “remains firmly on schedule, with a filing for marketing approval anticipated in 2008 following the conclusion of the ongoing, fully-recruited Phase III study.”