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Second European Country To Commence Cerepro(R) Treatment On Named Patient Basis, England

Ark Therapeutics Group plc (AKT:LSE) announces that Named Patient Supply (NPS) for Cerepro® (sitimagene ceradenovec) has been approved in Finland by the National Agency for Medicines (NAM). The approval follows an application made by a neuro-surgeon in Finland for the use of Cerepro®. Finland is the second country to approve NPS, the first being France which approved NPS in February 2009. NPS is used by clinicians when patients are faced with a terminal diagnosis and to allow the use of promising unapproved therapies after existing therapy has failed. Cerepro®, Ark"s novel gene-based medicine, is being developed as an Orphan Drug for the treatment of operable malignant glioma. The product has undergone four clinical trials and demonstrated significant efficacy benefits in patients with operable malignant glioma. A Marketing Authorisation Application (MAA) for Cerepro® is currently undergoing formal review at the European Medicines Agency (EMEA) via the centralised procedure which is the standard route for all advanced therapies. Dr Nigel Parker, CEO at Ark, said: "We are very pleased to report this second NPS approval. It is encouraging to see surgeons who have experience of the drug in clinical trials wanting to use the product in normal clinical practice. Glioma is a terrible disease with a poor prognosis and as such is an area of medicine where new treatments are much needed." Malignant glioma Malignant glioma is a devastating and fatal form of brain tumour that is usually confined to the brain. The current standard therapy involves surgically removing the solid tumour mass (when possible) and initiating radiotherapy and/or chemotherapy. Even with the latest approved treatments, many patients die within one year of diagnosis, with average survival being about fourteen months. Little therapeutic progress has been made in recent years and the prognosis for malignant glioma patients is poor. A high unmet clinical need exists for new treatments that prolong life in this devastating disease. There are approximately 16,000 cases of malignant glioma in the EU which are operable. Cerepro® 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. Ark Therapeutics Group plc


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