Ark Therapeutics Group plc, has filed the formal request to the European Medicines Agency (EMEA) for re-examination of its marketing authorization application (MAA) for Cerepro, Ark's novel gene-based therapy for operable malignant glioma (brain cancer). This follows the adoption of a negative opinion by the European Committee for Medicinal Products for Human Use (CHMP) in December 2009. Ark will provide data to support re-examination on the main underlying objection from its '904' phase-III trial and expects to receive a final decision from the EMEA in early Q2 2010.
The MAA application for Cerepro was filed in December 2008 and has undergone formal review via the centralised procedure. Cerepro has Orphan Drug Status in both Europe and the USA and is manufactured by Ark in Finland.
Nigel Parker, CEO at Ark, commented, "In the last two weeks we have assessed the full range of evidence from the phase-III study. We are confident that we have the necessary data to address the main underlying objection concerning the re-intervention decision in the Cerepro trial. The body of evidence is substantial and robust and we are thus comfortable to file for re-examination.”
"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. The trial endpoints and analyses used in Study 904 reflect the latest published recommendations from international expert working groups reviewing glioma trial design."
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 plc is a specialist healthcare group addressing high value areas of unmet medical need within vascular disease, wound care and cancer.