EMEA rejects early approval of Ark's Cerepro

London, UK-based Ark Therapeutics' Cerepro has been rejected by the European medicines regulatory authority, so that marketing approval cannot yet be given for the novel gene-based medicine for the treatment of operable high grade glioma (malignant brain tumour).

Although detailed feedback has yet to be received from the European Medicines Agency (EMEA), it is understood that the regulator believes there is not yet a sufficient weight of clinical evidence from the limited number of patients included in the Phase II data to conclude that the risk benefit for patients has been proven beyond doubt. So far, only 24 patients have received the final version of the agent in completed trials. Data from a larger Phase III trial should be available in 2008.

According to Ark, the Cerepro filing has determined the regulatory pathway and standards for approval of gene-based medicine in Europe and the product appears to have cleared all the historically problematic technical issues, including the chemistry and manufacturing controls, preclinical and environmental sections of the approval process.