The re-examination filing provides evidence from the Phase III trial (Study 904) in relation to possible bias in the decision to re-intervene, and the validity of the endpoint. The submission is supported by European and International experts in glioma, from the fields of neurosurgery and oncology. A decision from the EMA is expected by late Q1/early Q2 2010.
The MAA application for Cerepro was filed in November 2008 and has undergone formal review via the centralised procedure. The European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the MAA in December 2009. Cerepro has Orphan Drug Status in both Europe and the US and is manufactured by Ark in Finland.
Nigel Parker, CEO of Ark, said: “Ark has successfully pioneered the adenovirus platform to an approvable standard and we are now dealing with a final clinical issue in relation to the Cerepro trial implementation. Extensive analyses of the relevant parameters have been undertaken and we are comfortable to file for re-examination. We believe the body of evidence submitted is substantial and robust and overall in accordance with current international recommendations for glioma trials.”