Ark Therapeutics Group plc: European Patent Granted for Cerepro

17-Oct-2006

Ark Therapeutics Group plc announced that the European Patent Office has granted the Company a patent covering the use of Cerepro, its novel gene-based medicine for the treatment of operable high grade glioma (brain cancer). The patent grant gives protection in Europe until November 2019. Cerepro has already been granted patent protection in the USA, Australia, Mexico and China.

Cerepro is one of the first gene-based medicines to undergo full development. Post-operative treatment with Cerepro produces an average extension of 7.5 months of life, giving around 15.5 months survival in a disease where patients will on average only live for around eight months. Cerepro is currently undergoing regulatory review for marketing approval in Europe. The application was submitted to the European regulatory authority, the EMEA, by Ark in the second half of last year and responses to the first series of questions raised by the EMEA's scientific committee were recently filed by the Company. The outcome of the EMEA's review is expected by early 2007. Ark has also commenced a corroborative Phase III/IV study for Cerepro (Study 904), which is being undertaken in approximately 40 centres in Europe and Israel and aims to recruit up to 250 patients.

Cerepro has Orphan Drug Status in Europe and the USA. It is manufactured by Ark in its facility in Finland, the first factory ever to be approved to manufacture gene-based medicines for commercial supply in Europe.

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. In the following days, ganciclovir, is given intravenously. Once treated, healthy brain cells surrounding the site where the tumour was removed express the enzyme thymidine kinase. This converts the ganciclovir to a substance which specifically kills dividing cells. The healthy neurones surrounding the tumour in the brain are non-dividing and are therefore not susceptible to this substance. In this way Cerepro, harnesses healthy brain cells to help prevent a new tumour from growing.

https://www.bionity.com/en/news/58708/ark-therapeutics-group-plc-european-patent-granted-for-cerepro.html