PVG.L Regulatory News (PVG)

5 Oct 2005 07:00

Ark Therapeutics Group PLC05 October 2005 Ark completes development of oxLDL diagnostic kit for prediction of heart attack risk Product now CE-marked in preparation for commercialisation London, UK, 5 October 2005: Ark Therapeutics Group plc ("Ark"), today announcesthat it has completed the development and European CE marking of its oxidisedlow density lipoprotein antibody testing kit, oxLDL. The diagnostic kit will beused to predict whether an individual is at risk of having a heart attack. Patients with cardiovascular disease exhibit a build up of fats and abnormaltissue, known as atherosclerotic plaques, on the inside of their blood vessels.Whilst plaques can lay dormant with minimal risk to the patient, they can becomeactive and unstable, eventually rupturing and releasing fragments of plaque intothe bloodstream. This 'breakaway' plaque is circulated by the blood and canlodge in the coronary artery causing a heart attack, or in the blood vesselssupplying the brain causing a stroke. As plaque becomes active, it releases a specific chemical, an oxidised form oflow density lipoprotein (oxLDL), into the blood stream in amounts that reflectthe level of the plaque's instability. As such, oxLDL has become increasinglyrecognised as a key marker of heart attack risk(1), as the higher its level inthe blood, the more likelihood there is of the plaque breaking away and causinga serious cardiovascular event. Attempts to produce a reliable and easy to use test to measure oxLDL have notbeen successful to date, as the oxLDL molecule only exists for a very short timein the blood. However, as oxLDL is released into the blood, it rapidly producesan antibody response. Ark's test, the first of its kind, is a highly sensitivemeasure of the level of antibodies that are produced in response to oxLDL. Thetest also contains a control chemical to check whether a positive result is realor false. Clinical results to date using Ark's test have shown that the test is applicableto approximately 75% of people and is highly predictive. In a study of patientswith chest pain entering hospital for investigation, 81% of the patients whotested positive using Ark's kit were subsequently confirmed as having a seriouscardiovascular problem (heart attack or unstable angina). The test was evenmore accurate where heart attack occurred. C-reactive protein (CRP), one of thecurrent 'gold standards' in predicting risk of cardiovascular problems, waspredictive in only 29% of the cases in the same study. Professor John Martin, Chair of Cardiovascular Medicine at University CollegeLondon and Chief Scientific Officer at Ark, commented: "This new diagnostic ishighly predictive and has the potential to save many lives. It should prove avery useful addition to the overall cardiovascular risk testing approach." Dr Nigel Parker, Chief Executive of Ark, added: "This is the second product thatArk has taken all the way through the development process to CE marking. Weshall now be seeking specialist diagnostic partners to help us market theproduct and ensure that it realises its full commercial potential." 1) Tsimikas, S. et. al. New England Journal of Medicine 2005; 353: 46-57 Ark Therapeutics Group plc +4420 7388 7722 Dr Nigel Parker, CEO Paul Higham, Director of Commercial Development Financial Dynamics +4420 7831 3113 David Yates Davina Langdale Notes to Editors Cardiovascular risk testing market Cardiovascular disease is the largest single killer in the developed world,currently responsible for 40% of all deaths and the percentage continues torise. The WHO have stated that in five years' time cardiovascular disease willbe responsible for more deaths worldwide than cancer, tuberculosis and AIDScombined. Current medical practice is increasingly focussed on screening highrisk patients to treat them prophylactically to prevent a serious cardiovascularevent occurring. Current risk screening involves an assessment of the patient'shistory and lifestyle, together with a battery of tests eg cholesterol, highdensity lipoproteins, low density lipoprotein, triglycerides, CRP, homocysteine,none of which are thought to be individually highly predictive. This need fornew, more accurate diagnostics is well recognised. The market for existingcardiovascular diagnostic tests is currently estimated to be approximately$4billion and showing double digit percentage annual growth. Ark Therapeutics Group plc Ark is an emerging specialist healthcare group (the "Group") now entering thecommercialisation phase, with one marketed product and four further leadproducts in late stage clinical development. Capitalising on over ten years ofresearch in vascular biology and gene-based medicine, Ark has a balancedportfolio of proprietary healthcare products targeted at specific unmet clinicalneeds, predominantly within vascular disease and cancer. These are large andgrowing markets, where opportunities exist for effective new products togenerate significant revenues. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable Ark to take each productthrough development and to benefit from Orphan Drug Status and/or Fast TrackDesignation, as appropriate. The Group generally retains ownership of itsproduct candidates throughout clinical development and intends to conduct itsown sales and marketing in certain territories, as well as securing marketingpartners in others. The Group has operations in London, UK and Kuopio, Finland. Ark's shares are traded on the London Stock Exchange (AKT.L). More informationabout the Group can be found on its website at arktherapeutics.com. This information is provided by RNS The company news service from the London Stock Exchange