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Ark Therapeutics Grp - Regulatory Update |
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28 Apr 2007 |
EMEA decision on CereproTM Phase II filing
LONDON, UK | Apr 27, 2007 | Ark Therapeutics Group plc ('Ark' or the 'Company') today announces that it has been informed by the European medicines regulatory authority, the EMEA, that in their opinion marketing approval cannot yet be given for CereproTM, Ark's novel gene-based medicine for the treatment of operable high grade glioma (malignant brain tumour). Although detailed feedback has yet to be received from the EMEA, it is understood that the EMEA takes the view that there is not yet a sufficient weight of clinical evidence from the limited number of patients included in the Phase II data to conclude that the risk benefit for patients has been proven beyond doubt.
The CereproTM filing has determined the regulatory pathway and standards for approval of gene-based medicine in Europe and CereproTM appears to have cleared all the historically problematic technical issues, including the Chemistry and Manufacturing Controls (CMC), Preclinical and Environmental sections of the approval process. Only the nature and extent of the clinical data now appears outstanding. Overall this success represents one of the most significant advances for many years in this breakthrough area of biomedicine.
Ark will be examining the EMEA's detailed feedback relating to the outstanding concerns, when received, before deciding how to progress the regulatory approval process. These concerns may be able to be resolved through the provision of further data or analyses from the existing Phase II trials or new data may be required from the larger ongoing Phase III study (Study 904), which has recently completed recruitment on schedule.
Study 904 is being conducted as part of Ark's existing business plan and is a standard care-controlled trial to assess the efficacy and safety of CereproTM in 250 patients with high grade glioma. Patients are randomised in a 1:1 ratio, either to standard care alone, or to standard care plus CereproTM and patients are blinded to the point of treatment allocation. The multi-centre study is being conducted in Europe and Israel.
CereproTM has Orphan Drug Status in Europe and the USA. It is manufactured by Ark in its facility in Finland, the first facility ever to be approved to manufacture gene-based medicines for commercial supply in Europe. The Phase II clinical trials completed to date have shown that CereproTM treatment produces an average extension of 7.5 months of life, giving around 15.5 months survival compared to the standard care group, which survived around 8 months.
Nigel Parker, Chief Executive of Ark, commented:
'CereproTM was filed early as an Orphan Drug because it has shown significant patient benefit in both of its Phase II trials. Early approval would have been welcome upside news but the major successes in clearing manufacturing, preclinical and environmental sections of the filing are huge regulatory steps forward for CereproTM and for the prospects of gene-based medicines in Europe. Enthusiasm for CereproTM is illustrated by the rapid rate of recruitment into our Phase III study and we will continue to develop the product according to plan, with the goal of making it commercially available to glioma patients as soon as possible.'
SOURCE: Ark Therapeutics Group plc |
