Ark Files Cerepro(R) Application For Marketing Authorisation With EMEA

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Neurology / Neuroscience
Article Date: 02 Dec 2008 - 3:00 PDT

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Ark Therapeutics Group plc (AKT: LSE) ("Ark" or "the Company") today announces that the Marketing Authorisation Application (MAA) for Cerepro®, Ark's novel gene-based therapy for operable malignant glioma (brain cancer), has been filed with the European medicines regulatory agency (EMEA).

The MAA application for Cerepro®, filed following a pre-submission meeting with the EMEA, will now enter the validation stage, prior to commencing formal review. The MAA for Cerepro® will be reviewed via the centralised procedure which is the standard route for all advanced therapies.

Cerepro® was originally filed for marketing approval under exceptional circumstances, in late 2005 and was reviewed by the EMEA Committee for Medicinal Products for Human Use (CHMP) with reliance on Phase II data. The review established that the technical chemistry and manufacturing controls (CMC), preclinical and environmental sections appeared acceptable, but more clinical data were needed to confirm the Phase II findings and demonstrate the reproducibility of the results in a larger multi-centre trial.

Cerepro® has undergone four clinical studies during its development to date, the latest being a Phase III study in which the product showed a significant therapeutic benefit supporting the results of previous studies. An update of the results from this study is expected to be available in the first quarter of 2009. Cerepro® has Orphan Drug Status in Europe and the USA and is manufactured by Ark in Finland.

Dr David Eckland, Research and Development Director at Ark, said: "We are working in a breakthrough area of medicine, and in a terrible disease where new treatments are very much needed. This is an exciting time and we look forward to working with the EMEA during the review."

Dr Nigel Parker, CEO of Ark, commented: "We are very pleased to report this filing in accordance with our plans. Increasingly we see that gene based medicine has the potential to deliver solutions for many diseases that are untreatable today and Ark has become recognised as a world leader in this area of medicine."

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, most patients die within one year of diagnosis, with average survival being about eight 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

Ark Therapeutics Group plc is a specialist healthcare group (the "Group") addressing high value areas of unmet medical need within vascular disease, wound care and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues. With four marketed devices, Kerraboot®, Kerraped®, Flaminal® and Neuropad®, and three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam®, the Group is transitioning from an R&D company to a commercial, revenue generating business.

Ark's own products are sourced from related but largely non-dependent technologies within the Group and have been selected to enable them to be taken through development within the Group's own means and to benefit from Orphan Drug Status and/or Fast Track Designation, as appropriate. This strategy has allowed the Group to retain greater value and greater control of clinical development timelines, and to mitigate the risks of dependency on any one particular programme or development partner. Ark has secured patents or has patent applications pending for all its lead products in principal pharmaceutical markets.

Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Mr Stephen Barker of University College London and Professor Seppo Yla-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland, all of whom play leading roles in the Company's research and development programmes.

Ark's shares were first listed on the London Stock Exchange in March 2004 (AKT.L).

Ark Therapeutics Group plc