Ark Therapeutics Group has refiled its gene-based brain cancer drug Cerepro with regulators in Europe.

The London-headquartered group has submitted a marketing authorisation application for Cerepro (adenovirus-mediated Herpes simplex virus-thymidine kinase gene) for operable malignant glioma with the European Medicines Agency following a pre-submission meeting with the agency. The therapy was originally filed for approval under exceptional circumstances in late 2005 and was reviewed by the EMEA’s Committee for Medicinal Products for Human Use.

That review was based on Phase II data, and the CHMP, while saying that the technical chemistry and manufacturing controls appeared acceptable, demanded more clinical data to confirm the Phase II findings in a larger multi-centre trial. Ark believes this has now been achieved and in July published promising data from a preliminary analysis of a Phase III trial of Cerepro, which demonstrated that the treatment “resulted in significant improvements in median survival on the primary endpoint (survival) compared with various control groups.

Ark said an update of the results from this study is expected to be available in the first quarter of 2009. The firm added that Cerepro, which is manufactured at its facility in Finland, has orphan drug status in Europe and the USA.

David Eckland, R&D director at Ark, said the company is working in “a breakthrough area of medicine and in a terrible disease where new treatments are very much needed. This is an exciting time.”