PVG.L Regulatory News (PVG)

Ark Therapeutics Group plc

Positive results for Ark's pre-clinical product candidate EG013 in the treatment of foetal growth restriction

29 November 2010 - Ark Therapeutics Group plc ('Ark' or the 'Company') is pleased to announce very promising results from a number of collaborative research programmes for the use of Ark's EG013, its adenoviral vector containing a vascular endothelial growth factor (VEGF) gene in the treatment of foetal growth restriction (FGR) during pregnancy.

Studies, which were carried out in research centres of excellence throughout the UK and partly funded by the Wellcome Trust, demonstrated the beneficial effect in established FGR preclinical models. These prize winning studies in preclinical sheep models of foetal growth restriction demonstrated that following treatment with Ad.VEGF there was an increase in birth weight and that other standard measurements, including abdominal circumference (AC) and renal volume (RV) are significantly increased.

Martyn Williams, CEO of Ark Therapeutics commented: "Recently we announced a corporate re-structuring of our business a key element of which is an increased focus upon our innovative early stage platforms and products. FGR is a serious condition affecting approximately 8% of all pregnancies and is severe in 1 in 500 foetuses.

Taken together these studies demonstrate that through our research collaborations in UK centres of excellence we have achieved significant results in recognised FGR pre-clinical models which will allow us to accelerate the development of the EG013 programme towards the clinic. They show the beneficial effect of adenoviral VEGF on the target tissue and the lack of adverse effect on the placenta. Further studies are underway to prepare for definitive toxicology and clinical studies."

Overview of results and investigator quotes:

EG013 is an adenoviral vector containing the vascular endothelial growth factor (VEGF) gene (Ad.VEGF-DΔNΔC) under development by Ark for the treatment of severe FGR in pregnant women during the second trimester. FGR affects up to 8% of pregnancies and is severe in approximately 1 in 500 foetuses. Cases of severe FGR occur when foetal growth velocity slows or foetal growth ceases altogether mid-pregnancy. Affected foetuses are extremely small, (Inadequate uterine blood flow, termed uteroplacental insufficiency, is the underlying abnormality in many cases of FGR, for which there is no medical therapy currently available.

In collaboration with Ark, the pre-clinical studies were partly funded by the Wellcome Trust, carried out by researchers at University College London (UCL) and the Rowett Institute of Nutrition and Health (University of Aberdeen). They show that Ad.VEGF treatment of a preclinical sheep model of foetal growth restriction can increase birth weight (by 20%)(treatment 4.11kg vs control 3.43kg, p=0.08). The change in abdominal circumference (AC) and renal volume (RV) (other important markers of foetal well-being and growth) also increased, and these were statistically significant at 21 (16% increase for AC, p=0.005; 23.5% increase for RV, p=0.005) and 28 days (15% increase for AC, p=0.004; 17% increase for RV, p=0.035) after Ad.VEGF injection.

Dr Jacqueline Wallace (Senior Scientist, Rowett Institute) commented: "Overall, these results are highly indicative of the desired treatment effect. There were no adverse outcomes in the VEGF treated groups either during pregnancy or in the period to weaning. "

Dr Anna David (Senior Lecturer, UCL) said "These are extremely encouraging results, showing that we may be able to improve the growth of severely affected babies sufficiently to be healthy when they are born. We hope to be able to help vulnerable pregnancies progress to a successful outcome in the future".

In a further series of experiments in collaboration with the University of Manchester, in vitro studies with human placenta exposed to adenovirus have been performed. Fragments of placenta were grown in culture for 5 days, and then exposed to adenovirus at various concentrations or control material. This exposure to adenovirus had no detrimental effect on placental function as measured by hormone secretion or enzyme activity. Neither was there any adverse effect on the cellular structure of the placental tissue.

Professor Colin Sibley (Professor of Child Health and Physiology, The University of Manchester) said: "We are delighted with these results which help to show that it may be possible to treat mothers with adenoviral VEGF without causing harm to the placenta. At present we are unable to do anything to help these unfortunate patients."

The presentation of the studies from the Rowett Institute, outlined above, at the Annual Academic Meeting of the Royal College of Obstetricians and Gynaecologists (18-19 November 2010) was awarded first prize in the Blair Bell Research Society competition.This is the national meeting for clinical academics and scientists in Reproductive Health and the competition was judged by a panel of senior academics

http://www.rcog.org.uk/events/annual-academic-meeting-obstetrics-and-gynaecology

This work will also form the basis of an oral presentation at the Society for Gynaecologic Investigation meeting in Miami in March 2011.

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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 and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues.

Ark has an early stage pipeline emanating from collaborations with University College, London and the AI Virtanen Institute in Kuopio, Finland, the development of which it intends to progress in collaboration with pharmaceutical and biotech partners.

In addition Ark has the ability to off-set a proportion of its R&D costs and to generate sustainable revenues through the exploitation of its proprietary technology platform, process development, scale-up and manufacturing capabilities on behalf of third parties.

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 remain consultants on 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.