London, UK, 4 September 2009 – Ark Therapeutics Group plc (“Ark” or the “Company”) today announces that it has received positive feedback from a formal scientific advice meeting with the Medicines and Healthcare products Regulatory Agency (“MHRA”) regarding the pre-clinical toxicology and Phase I trial requirements for EG013, an adenovirally mediated VEGF based product being developed to treat severe foetal growth restriction (“FGR”). The MHRA commented on the nature of the pre-clinical models, toxicology programme and the design of a Phase I trial.
The MHRA concluded that the choice of species and overall design of the toxicology programme, including a series of in vitro studies using human placenta, are suitable to support a Phase I study. The nature and quality of the proposed vector are also suitable, and the release characteristics for the vector were clarified. The outline design of the Phase I study was considered suitable for a first-in-man study, and the entry criteria were clarified.
Severe foetal growth restriction is often a terminal condition in which insufficient blood supply to the placenta results in serious growth retardation, leading to premature death or undesired termination of a baby or long term neurological problems in surviving infants. The problem is usually first diagnosed around 20 weeks into pregnancy and at present there is no effective treatment.
Results from the first two trials of EG013 in a pre-clinical model of placental blood flow have shown that a single treatment with EG013, given directly into the mother’s uterine artery, increased blood flow to the placenta by 25%, and that the effect was maintained for 50 days. Biodistribution data have shown no long term presence of the vector in the foetal tissues, as is essential for this form of gene therapy. If this efficacy is confirmed in human studies, a therapy with this magnitude and duration of effect could allow the foetus to grow satisfactorily to a stage where caesarean delivery of a healthy baby could be reliably performed. Ark has chosen the short form of VEGF-D as the most suitable agent to be used in FGR. The gene for this agent will be delivered using the standard Ark adenoviral platform, as developed in the Company’s Kuopio centre. Work on this project is continuing in both Finland and the UK.
Foetal growth restriction, in its various forms, affects approximately 60,000 babies in the USA and Europe. The work is being undertaken as a collaboration between Ark’s scientists at University College London (UCL) and the UCL Department of Obstetrics and Gynaecology. In addition, Ark has formed a collaboration with the Department of Maternal and Foetal Medicine at the University of Manchester, to utilise their expertise in assessing the effect of EG013 on human placenta in vitro.
Commenting on the meeting with the MHRA, Dr David Eckland, Director of Research and Development at Ark, said: “Foetal growth restriction is a very distressing condition and EG013 has already shown early signs of promise. The meeting with the MHRA is very encouraging and allows us confidently to continue the development of EG013 through the pre-clinical stage to a Phase I human study.”
Dr Nigel Parker, CEO of Ark, added: “We are very pleased to receive this input from the MHRA. Their support is further validation of our gene-based medicine technology and expertise and we look forward to progressing this programme with our collaborators.”
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.
