Ark Therapeutics says that regulators in Europe have agreed to review Cerepro, the UK firm’s gene-based therapy for brain cancer.
The London-headquartered group submitted a marketing authorisation application for Cerepro (adenovirus-mediated Herpes simplex virus-thymidine kinase gene) for operable malignant glioma with the European Medicines Agency at the end of last year. The EMEA will now commence a formal review via the centralised procedure, “the standard route for all advanced therapies”, Ark says.
The route up to now has not been a standard one, however. Cerepro was originally filed for marketing approval under exceptional circumstances in late 2005 and was reviewed by the EMEA using just Phase II data. However the regulator said that more clinical data were needed to demonstrate the reproducibility of those results in a larger multi-centre Phase III trial, which was completed in July 2007.
Nigel Parker, Ark’s chief executive, said that the acceptance of the Cerepro submission is a further significant milestone for the firm. He added that “gene-based medicine has made enormous progress both clinically and with the regulatory authorities in the last couple of years and it is the most advanced of the new biological therapeutics”.
Dr Parker went on to note that “the interest we are beginning to see in Cerepro as we get nearer to market is indicative of the potential that this whole area offers in finding new therapies that can make a real clinical difference for patients with hitherto untreatable diseases”.
