PVG.L Regulatory News (PVG)

19 May 2008 07:00



Ark makes significant advances with EG013 and EG014 preclinical programmes

19 May 2008 - Ark Therapeutics Group plc ("Ark" or the "Company") today provides an update on two of its preclinical programmes, EG013 and EG014. In November 2007, Ark raised £35.4 million net through a Placing and Open Offer to allow investment in a number of advanced preclinical programmes within its gene-based medicine portfolio that had promising results and the potential to move rapidly into the clinic.

EG013 is a Trinam® variant VEGF based gene medicine under development for fetal growth restriction, an often terminal condition where insufficient blood supply via the placenta results in serious growth retardation, leading to premature death or undesired termination of a baby in an otherwise healthy mother or long term neurological problems in surviving infants. The problem is usually first diagnosed about 20 weeks into pregnancy and at present there is no effective treatment.

Results from the first trial in a preclinical model of blood flow to the placenta have shown that a single treatment with EG013, given directly into the mother's uterine artery, increased blood flow to the placenta by 25%, an improvement that is believed adequate to treat the condition. The latest results of the second set of experiments have shown that the significantly increased blood flow after treatment with EG013 is maintained out to 50 days. If confirmed in human studies, a therapy with this magnitude and duration of effect could allow the fetus to grow satisfactorily to a stage where caesarean delivery of a healthy baby could be reliably performed. Preliminary biodistribution results using immunohistochemical techniques have indicated that there is no transfer of the gene into the fetus.

Fetal growth restriction, in its various forms, affects approximately 60,000 babies in the USA and Europe and is an extremely distressing condition. 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.  An abstract describing the work was recently presented at an American Society of Gynaecological Investigation where it won a President's Investigator award.

Commenting on the results, Professor Donald Peebles, Professor of Obstetrics and Fetal Medicine at UCL undertaking the work, said: "The results from this second set of experiments are again very encouraging. The robust science behind the gene-based product led us to believe we would see this effect but it is always exciting to have the theory confirmed. In common with many of the new types of advanced biologics treatments that are coming through, it looks as if we may be on the verge of a major treatment breakthrough in an extremely distressing medical condition." 

EG014 is Ark's gene derived small molecule anti-cancer programme centred around the neuropilin 1 (NP1) receptor. Previously reported preclinical results from Ark's early leads have shown that blocking of the NP1 receptor has a triple effect, killing tumour cells, reducing blood flow to tumours and inhibiting metastatic spread of the cancer. Work this year using advanced crystallography and computational chemical modelling has led to the recent discovery and understanding of the precise NP1 receptor pocket structure and molecular binding site characteristics. Additionally Ark has completed development of novel fast screening assays, highly specific to the above mentioned receptor. These developments are significant advances which now direct Ark's chemistry to optimise the existing leads.

Commenting on this, Professor John Martin, Chief Scientific Officer at Ark, said: "The previous preclinical results with NP1 indicated its potential as a broad treatment for cancer. This precise finding had eluded us for a number of months and we are delighted to have made this discovery in such a precise and detailed manner. This allows us to continue what we believe is the last stage of our lead optimisation work in a controlled and systematic way to give us compounds with the right potency and binding specificity to take into the clinic."

Nigel Parker, CEO at Ark, added: "In the second half of last year we received strong support to progress a number of preclinical programmes and we are very pleased to report this steady and solid progress by our research groups in two of the projects. It is extremely exciting for us to see this breakthrough science move forward and the progress confirms our view that advanced molecular medicine has the potential to offer breakthrough treatments in areas of serious unmet clinical needs. We look forward to updating the market on progress with these and our other preclinical projects in due course."

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Notes to Editors

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 four marketed devices, Kerraboot®, Kerraped®, Flaminal® and Neuropad®, 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). 

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.