Posted on: 8 January 2009, source: Biospace
Ark Therapeutics announced that the Marketing Authorisation Application (MAA) for Cerepro®, Ark’s novel gene-based therapy for operable malignant glioma (brain cancer) which was recently filed with the EMEA, has cleared the validation stage. The Cerepro® MAA application now commences formal review via the centralised procedure which is the standard route for all advanced therapies.
Cerepro® was originally filed for marketing approval in late 2005 and was reviewed by the EMEA with reliance on Phase II data. The review established that the technical chemistry and manufacturing controls (CMC), preclinical and environmental sections appeared acceptable, but more clinical data were needed to confirm the Phase II findings and to demonstrate the reproducibility of the results in a larger multi-centre Phase III trial.