Ark Therapeutics Group plc announces that the Marketing Authorisation Application (MAA) for Cerepro, Ark's novel gene-based therapy for operable malignant glioma (brain cancer), has been filed with the European medicines regulatory agency (EMEA).
The MAA application for Cerepro, filed following a pre-submission meeting with the EMEA, will now enter the validation stage, prior to commencing formal review. The MAA for Cerepro will be reviewed via the centralised procedure which is the standard route for all advanced therapies.
Cerepro was originally filed for marketing approval under exceptional circumstances, in late 2005 and was reviewed by the EMEA Committee for Medicinal Products for Human Use (CHMP) 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 demonstrate the reproducibility of the results in a larger multi-centre trial.
Cerepro has undergone four clinical studies during its development to date, the latest being a phase-III study in which the product showed a significant therapeutic benefit supporting the results of previous studies. An update of the results from this study is expected to be available in the first quarter of 2009. Cerepro has Orphan Drug Status in Europe and the USA and is manufactured by Ark in Finland.
Dr David Eckland, Research and Development director at Ark, said, "We are working in a breakthrough area of medicine, and in a terrible disease where new treatments are very much needed. This is an exciting time and we look forward to working with the EMEA during the review."
Dr Nigel Parker, CEO of Ark, commented, "We are very pleased to report this filing in accordance with our plans. Increasingly we see that gene based medicine has the potential to deliver solutions for many diseases that are untreatable today and Ark has become recognised as a world leader in this area of medicine."
Cerepro is an adenoviral mediated gene-based medicine (ad.HSV tk) given by multiple injections into the healthy brain tissue of patients following surgical removal of the solid tumour mass.
Ark Therapeutics Group is a specialist healthcare group addressing high value areas of unmet medical need within vascular disease, wound care and cancer.