5th Jan 2010 07:00
Ark files for re-examination of Cerepro®
Final decision from the European Agency anticipated early Q2
London, UK, 5 January 2010 - Ark Therapeutics Group plc (AKT: LSE) ("Ark" or "the Company"), announces that it has filed the formal request to the European Medicines Agency (EMEA) for re-examination of its marketing authorization application (MAA) for Cerepro®, Ark's novel gene-based therapy for operable malignant glioma (brain cancer). This follows the adoption of a negative opinion by the European Committee for Medicinal Products for Human Use (CHMP) in December 2009. Ark will provide data to support re-examination on the main underlying objection from its "904" phase III trial and expects to receive a final decision from the EMEA in early Q2 2010.
The MAA application for Cerepro® was filed in December 2008 and has undergone formal review via the centralised procedure. Cerepro® has Orphan Drug Status in both Europe and the USA and is manufactured by Ark in Finland.
Nigel Parker, CEO at Ark, commented; "In the last two weeks we have assessed the full range of evidence from the Phase III study. We are confident that we have the necessary data to address the main underlying objection concerning the re-intervention decision in the Cerepro® trial. The body of evidence is substantial and robust and we are thus comfortable to file for re-examination.
"Ark has successfully pioneered the adenovirus platform to an approvable standard and we are now dealing with a final clinical issue, through the standard EMEA regulatory process. The trial endpoints and analyses used in Study 904 reflect the latest published recommendations from international expert working groups reviewing glioma trial design."
For further information:
|
Ark Therapeutics Group plc Dr Nigel Parker, CEO Martyn Williams, CFO |
Tel: +44 (0)20 7388 7722 |
|
Financial Dynamics Ben Atwell Susan Quigley |
Tel: +44 (0)20 7831 3113 |
Notes to Editors
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, 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®
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.
About 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 six marketed devices, Kerraboot®, Kerraped®, Flaminal®, Neuropad®, KerraMax® and Kerraglove®, three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam® and two in Phase I/IIa trials, EG011 and EG016 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 Ylä-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).
This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.
Related Shares:
PVG.L