PVG.L Regulatory News (PVG)

1 Feb 2007 07:01

Ark Therapeutics Group PLC01 February 2007 Ark Therapeutics-led consortium awarded €2.5 million European Commission grant to fund research into baculoviral vectors for gene medicine February 1, 2007: Ark Therapeutics Group plc ("Ark") announces today the awardof a European Commission grant of €2.5m to fund a consortium of commercial andacademic collaborators led by Ark to conduct research into advancing the use ofinsect derived viruses known as baculoviruses (BVs) as vectors for gene-basedmedicines. Ark will administer and lead the research project, providing keygene-based technologies and expertise from London and Finland whilstcollaborating with researchers in Germany, France, The Netherlands and Portugal. The grant will support the BACULOGENES project which aims to develop clinicallysuitable methods for the development, production, testing and validation of nextgeneration stabilised and selective BV vectors for gene medicine applications.Target diseases for in vivo gene delivery with selectively targeted BVs includemuscle disorders, age-related macular degeneration and prostate cancer. Delivering therapeutic DNA into cells is one of the most promising therapeuticplatforms under development for treating a large scope of pathologies, rangingfrom genetic disorders to degeneration syndromes and cancers. Adenoviral vectorgene medicine based on the common cold virus is now established as the leadingtechnology, proving safe and effective. However, other vectors currently beingexplored in research still have limitations mainly relating to safety and genedelivery capabilities requiring further research Ark is a pioneer in the use of BVs for mammalian gene transfer applicationswhere its existing BVs have already shown promising results. The consortium willdevote its efforts not only to BV gene therapy applications, but also to thedevelopment of large scale production, downstream processing, purification andanalysis methods, together with the quality control and validation assays, andall issues related to regulatory aspects required for the clinical exploitationof BV technology. Ark will retain certain IP and commercial rights to thefuture applications depending on the results of the various programmes. The project filed under the European Commission Framework 6 initiative, wasassessed on a variety of parameters including scientific and technologicalexcellence, relevance, consortium quality and management capabilities. Ark'sconsortium scored 28 out of a maximum of 30, achieving one of the highest scoresfor applications in this Framework area. Ark is a world leader in the area of gene-based medicine, with two gene products(CereproTM and Trinam(R)) in Phase III development and a range of earlier genemedicine platforms, including Scavidin(R), as well as targeted vector 'clip'technologies. It is the only company with a manufacturing facility licensed toproduce gene medicines for commercial sale in Europe. Ark has over 100employees at its main gene medicine research and manufacturing facility inKuopio, Finland and conducts further gene related research in London. Commenting on the award Dr Nigel Parker CEO said: "This is a real achievement for our scientists. They have put many years ofdedicated effort into the technology of gene-based medicines. To havesuccessfully driven the project leading to the award of such a significant grantand to achieve such a high score in what is recognised as a rigorously peerreviewed process is a real credit to them." For further information please contact: Ark Therapeutics Group plc: +44 (0)20 7388 7722Dr Nigel Parker, CEOMartyn Williams, CFO Financial Dynamics: +44 (0)20 7831 3113David YatesAnna Keeble Notes to Editors Baculoviruses Baculoviruses are insect viruses which are not known to replicate in mammaliancells, giving them an advantage in terms of safety over classical mammalianviruses currently used as vectors such as adeno-associated viruses, retrovirusesand lentiviruses. The most promising BV to date appears inherently safe and candeliver up to five times more DNA than previous vectors. BV is not known to beassociated with any human disease. BV technology has been used for many years for producing recombinant proteinsand thus large scale production technology is readily adaptable for theexploitation of gene medicine approaches. 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, woundcare and cancer. These are large and growing markets, where opportunities existfor effective new products to generate significant revenues. With two marketeddevices, Kerraboot(R), and Flaminal(R), and three further lead pharmaceuticalproducts in late stage clinical development: CereproTM, VitorTM, and Trinam(R),the Group is transitioning from an R&D company to a commercial, revenuegenerating business. Ark's existing products are sourced from related but largely non-dependenttechnologies within the Group and have been selected to enable them to be takenthrough development within the Group's own means and to benefit from Orphan DrugStatus and/or Fast Track Designation, as appropriate. This strategy has allowedthe Group to retain greater value and greater control of clinical developmenttimelines, and to mitigate the risks of dependency on any one particularprogramme or development partner. Ark has secured patents or has patentapplications pending for all its lead products in principal pharmaceuticalmarkets. Ark has its origins in businesses established in the mid-1990s by Professor JohnMartin and Mr Stephen Barker of University College London and Professor SeppoYla-Herttuala of the AI Virtanen Institute at the University of Kuopio,Finland, all of whom play leading roles in the Company's research anddevelopment 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 allstatements other than statements of historical facts, including, withoutlimitation, those regarding the Group's financial position, business strategy,plans and objectives of management for future operations (including developmentplans and objectives relating to the Group's products and services), and anystatements preceded by, followed by or that include forward-looking terminologysuch as the words 'targets', 'believes', 'estimates', 'expects', 'aims','intends', 'will', 'can', 'may', 'anticipates', 'would', 'should', 'could' orsimilar expressions or the negative thereof. Such forward-looking statementsinvolve known and unknown risks, uncertainties and other important factorsbeyond the Group's control that could cause the actual results, performance orachievements of the Group to be materially different from future results,performance or achievements expressed or implied by such forward-lookingstatements. Such forward-looking statements are based on numerous assumptionsregarding the Group's present and future business strategies and the environmentin which the Group will operate in the future. Among the important factors thatcould cause the Group's actual results, performance or achievements to differmaterially from those in forward-looking statements include those relating toArk's funding requirements, regulatory approvals, clinical trials, reliance onthird parties, intellectual property, key personnel and other factors. Theseforward-looking statements speak only as at the date of this announcement. TheGroup expressly disclaims any obligation or undertaking to disseminate anyupdates or revisions to any forward-looking statements contained in thisannouncement to reflect any change in the Group's expectations with regardthereto or any change in events, conditions or circumstances on which any suchstatements are based. As a result of these factors, readers are cautioned not torely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange