London, UK – 18 January 2008 - Ark Therapeutics announces today that, following a recent independent Data and Safety Monitoring Board (“DSMB ") review of its Phase III trial for Cerepro® (Study 904), the Company will continue to follow patients in the study until the end of June. At this point the Company will have a sufficiently full data set to provide reliable statistical evaluations of the clinical effects of Cerepro®. Cerepro® is Ark’s lead product for the treatment of high grade glioma (malignant brain tumour).
Dr Nigel Parker, CEO of Ark, commented: “This trial has the potential to provide us with key efficacy results. For this we need the full data set and, at present, we still have around 40% of patients who have been in the trial less than a year. Thus we will need to be patient.”
Enquiries
Ark Therapeutics plc Tel: +44 (0)20 7388 7722 Dr Nigel Parker, Chief Executive Officer Martyn Williams, Chief Financial Officer
Financial Dynamics Tel: +44 (0)20 7831 3113 David Yates / Sue Quigley
Notes to Editors
Study 904 Study 904 is a standard care controlled study to assess the efficacy and safety of Cerepro® 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 Cerepro® treatment and patients are blinded to the point of treatment allocation. The multi-centre study is being conducted in Europe and Israel.
Trials completed to date have shown that Cerepro® treatment produces an average extension of 7.5 months of life, giving around 15.5 months survival, whereas controls survived on average for around 9 months.
High grade glioma
High grade glioma (malignant glioma) is a devastating and fatal form of 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. It is estimated that 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.
Cerepro® is manufactured by Ark at its cGMP facility in Finland, which was granted the first ever European commercial gene therapy production licence in late 2005.
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 three marketed devices, Kerraboot®, Kerraped® and Flaminal®, and three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam®, 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).
