LONDON, 24 April 2007 -Ark Therapeutics Group plc ('Ark' or the 'Company') today announces that it has completed recruitment into the Phase III trial (Study 904) for CereproTM, its novel gene-based medicine for the treatment of operable high grade glioma (malignant brain tumour).
Study 904 is a standard care-controlled study 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.
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 in a disease where most patients will only live for around 8 months.
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.
CereproTM is currently undergoing regulatory review for early marketing approval with the European regulatory authority (EMEA), based on the data from already completed Phase II trials. The Company expects the review to be completed shortly.
Nigel Parker, Chief Executive of Ark, commented:
'Completion of recruitment into this Phase III study is a key milestone for CereproTM and we are pleased to report this news according to plan. The increasingly rapid recruitment into this trial has been very encouraging and reflects the enthusiasm amongst neurosurgeons for this much-needed product and the growing appeal of gene-based therapies. CereproTM has previously demonstrated that it is able almost to double average patient survival time offering significant hope to patients who develop malignant glioma. It is also the first gene-based medicine1 to undergo full regulatory review and we look forward to updating investors on the outcome of the EMEA's review in the near future.'
Note 1: outside China
For further information please contact:
Ark Therapeutics +44 (0)20 7388 7722
Dr Nigel Parker, Chief Executive Officer
Martyn Williams, Chief Financial Officer
Financial Dynamics +44 (0)20 7831 3113
David Yates / Anna Keeble
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, most patients die within one year of diagnosis, with average survival being about eight 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 per annum which are operable.
CereproTM
CereproTM 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, CereproTM harnesses healthy brain cells to help prevent a new tumour from growing.
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 two marketed devices, Kerraboot(R), and Flaminal(R), and three further lead pharmaceutical products in late stage clinical development: CereproTM, VitorTM, and Trinam(R), 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 Yla-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. |
