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Re: BioSpecialist post# 62737

Monday, 05/19/2008 3:27:35 AM

Monday, May 19, 2008 3:27:35 AM

Post# of 252460
re Ark therapeutics -- News

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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