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Ark files documentation on Cerepro

Ark Therapeutics Group has requested re-examination of the marketing approval application for its brain cancer drug, Cerepro, from the EMA

Ark Therapeutics Group has filed documentation with the European Medicines Agency (EMA) in relation to its request for re-examination of the marketing approval application (MAA) for Cerepro, Ark's novel gene-based therapy for the treatment of operable malignant glioma (brain cancer).

The re-examination filing provides evidence from the phase III trial (Study 904) in relation to possible bias in the decision to re-intervene, and the validity of the endpoint. The submission is supported by experts in glioma from the fields of neurosurgery and oncology. The EMA's decision is expected by late Q1/early Q2 2010.

The MAA application for Cerepro was filed in November 2008 and underwent formal review via the centralised procedure. The European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the MAA in December 2009. Cerepro has Orphan Drug Status in Europe and the US.

Nigel Parker, CEO at Ark, commented: "Ark has successfully pioneered the adenovirus platform to an approvable standard and we are now dealing with a final clinical issue in relation to the Cerepro trial implementation. Extensive analyses of the relevant parameters have been undertaken and we are comfortable to file for re-examination. We believe the body of evidence submitted is substantial and robust and overall in accordance with current international recommendations for glioma trials."

Malignant glioma is a 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 14 months. A high, unmet clinical need exists for new treatments that prolong life.

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 that specifically kills dividing cells. The healthy neurones surrounding the tumour are non-dividing and are therefore not susceptible to this substance.

Ark specialises in addressing areas of unmet medical need in vascular disease, wound care and cancer. Its three lead pharmaceutical products in late stage clinical development are Cerepro, Vitor and Trinam.

24th February 2010

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