Ark Therapeutics Group plc has filed documentation with the European Medicines Agency (EMEA) 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 EMA have acknowledged receipt of the filing.
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 European and International experts in glioma, from the fields of neurosurgery and oncology. A decision from the EMA is expected by late Q1/early Q2 2010.
The MAA application for Cerepro was filed in November 2008 and has undergone 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 both Europe and the USA and is manufactured by Ark in Finland.
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 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 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 is a specialist healthcare group addressing high value areas of unmet medical need within vascular disease, wound care and cancer.