PVG.L Regulatory News (PVG)

21 Jan 2005 07:00

Ark Therapeutics Group PLC21 January 2005 Ark Granted Patent in Europe for Trinam(R) London, UK, 21st January 2005: Ark Therapeutics Group plc today announces thatit has been issued with a patent by the European Patent Office for Trinam(R),its novel therapy to prevent blood vessels blocking after vascular graft accesssurgery. Subject to the payment of renewal fees, this patent can be maintaineduntil at least 2016. Trinam(R), which is one of Ark's four lead products, is a combination of aVascular Endothelial Growth Factor (VEGF) gene in an adenoviral vector and Ark'sbiodegradable collagen collar local delivery device (EG001). The initial targetmarket for Trinam(R) is haemodialysis access graft surgery, a treatment forkidney failure patients where a plastic tube is grafted between blood vessels inthe forearm to enable regular blood filtration. At the end of the access graftsurgery procedure, the EG001 delivery device is fitted around the outside of thevein where it had been joined to the access graft. The VEGF gene in solution isthen injected into the reservoir formed between the delivery device and theblood vessel, from where it passes into the blood vessel wall, transfecting thesmooth muscles cells in the wall - a process known as adventitial transfection.This unique method of administration allows Trinam(R) to be localised to thetarget site where the therapy is needed. In the US and Europe, there are an estimated 150,000 cases a year whereTrinam(R) might be used. In patients with haemodialysis access grafts, up to60% of the grafts block within a year of being inserted, and repeat surgeryshows more rapid failure rates. Trinam(R) is expected to extend the usefullife of access grafts and reduce costly repeat procedures. There are currentlyno approved drug therapies to reduce the failure rates of access graftprocedures for haemodialysis patients. Preclinical studies have demonstrated a significant effect in preventing intimalhyperplasia and successful adventitial gene transfer. Trinam(R) is currentlyin Phase II clinical trials in the USA. The Phase II ascending dose study in upto 20 patients is designed to examine the efficacy and safety of Trinam(R) inpatients undergoing haemodialysis access graft surgery. Dr Alan Boyd, Research and Development Director of Ark, commented; "UsingTrinam(R) to prevent the problem of access graft blockage is a novel conceptthat was developed through a collaboration between our research groups in the UKand Finland. As such, the granting of this patent is an important validation ofour research ideas and science." Enquiries: Ark Therapeutics Group plc 020 7388 7722Dr Nigel Parker, CEOAlan Boyd, Research and Development Director Financial Dynamics 020 7831 3113David YatesLucy Briggs Ark Therapeutics Group plc Ark is a specialist healthcare group (the "Group") with one marketed product andthree further lead products in late stage clinical development. Capitalising onover ten years of research in vascular biology and gene-based medicine, Ark hasa balanced portfolio of proprietary healthcare products targeted at specificunmet clinical needs 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. Ark has secured patents orhas patent applications pending for all its lead products in principalpharmaceutical markets and retains the right to market its lead products inthe key North American and European markets. Ark has its origins in businesses established in the mid-1990s by Professor JohnMartin and Dr 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 successfully listed through an initial public offering on theLondon 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, prospective investors arecautioned not to rely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange