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Ark Therapeutics Group plc (AKT: LSE) (”Ark” or “the Company”), announces that it has filed certification with the European Medicines Agency (”EMA”) in telling to its asking for re-examination of the merchandising approving lotion (”MAA”) for Cerepro®, Ark’s fresh factor based therapy for the handling of practicable malignant glioma (mentality cancer ). The EMA bear acknowledged acknowledge of the filing.

The re-examination filing provides tell from the Phase III visitation (Study 904) in congress to potential prejudice in the determination to re-intervene, and the robustness of the terminus. The compliance is supported by European and International experts in glioma, from the fields of neurosurgery and oncology. A decisiveness from the EMA is expected by previous Q1/early Q2 2010.

The MAA diligence for Cerepro® was filed in November 2008 and has undergone courtly inspection via the centralized function. The European Committee for Medicinal Products for Human Use (CHMP) adoptive a disconfirming ruling 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 program to an approvable measure and we are now dealings with a net clinical issuing in intercourse to the Cerepro tryout execution. Extensive analyses of the relevant parameters suffer been undertaken and we are well-fixed to register for re-examination. We think the consistence of manifest submitted is strong and rich and boilersuit in accord with flow outside recommendations for glioma trials.”

Malignant glioma is a withering and black shape of brainpower tumor that is ordinarily jailed to the head. The stream received therapy involves surgically removing the unanimous tumor volume (when potential) and initiating radiation and/or chemotherapy. Even with the up-to-the-minute sanctioned treatments, many patients die inside one year of diagnosing, with mean endurance existence astir xiv months. Little alterative build has been made in late years and the forecast for malignant glioma patients is misfortunate. A mellow unmet clinical motive exists for new treatments that sustain biography in this annihilating disease. There are roughly 16,000 cases of malignant glioma in the EU which are functional.

Cerepro® is an adenoviral mediated gene-based medicate (ad.HSV tk) disposed by multiple injections into the respectable mentality weave of patients undermentioned operative remotion of the unanimous tumor volume. In the chase years, ganciclovir, is granted intravenously. Once toughened, respectable head cells encompassing the situation where the tumor was remote limited the enzyme deoxythymidine kinase. This converts the ganciclovir to a center which specifically kills dividing cells. The respectable neurones circumferent the neoplasm in the encephalon are non-dividing and are thus not susceptible to this heart. In this way Cerepro® harnesses respectable nous cells to avail preclude a new neoplasm from ontogeny.

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