Ark Therapeutics files for EMEA re-examination of Cerepro

Ark Therapeutics has issued a formal request to the European Medicines Agency (EMEA) to have its marketing authorisation application for its gene-based therapy for operable malignant glioma (brain cancer) re-examined.

In a statement, the medical company explained that it will provide the EMEA with data to support the re-examination and expects to have a final decision from the agency early in the second quarter of this year.

Nigel Parker, Ark Therapeutics’ chief executive officer, said that the company is confident that it has a body of evidence to ensure that the drug is given a positive opinion.

“Ark has successfully pioneered the adenovirus platform to an approvable standard and we are now dealing with a final clinical issue, through the standard EMEA regulatory process,” he added.

The original application for Cerepro was submitted to the agency by the company in November 2008 and underwent formal review via the EMEA’s centralised procedure before a negative opinion was adopted in December 2009.