PVG.L Regulatory News (PVG)

21 Jul 2005 07:01

Ark Therapeutics Group PLC21 July 2005 Trinam(R) Successfully Completes First Stage of Phase II Study Preliminary data to be presented at ACS in October 2005 - Abstract awarded "Exceptional Merit" London, UK, 21 July 2005: Ark Therapeutics Group plc ("Ark" and the "Company"),the emerging healthcare group, today announces that it has completed patientenrolment for the low dose arm of its Phase II study for Trinam(R) (EG004) andhas received approval to move to the higher dose. Trinam(R) is Ark's noveltherapy to prevent blood vessels blocking (intimal hyperplasia) after vasculargraft access surgery in kidney failure patients. The preliminary results of the first stage will be presented at the annualmeeting of the American College of Surgeons (ACS) in San Francisco, October 16 -20 2005. The abstract is one of twelve selected from the 309 abstractsinitially submitted to have been awarded "Exceptional Merit", and one of onlytwo in the vascular category. The Phase II study in up to 20 patients, is taking place at three centres in theUSA and is an open label ascending dose study, designed to examine the effectsand safety of Trinam(R) in intimal hyperplasia prevention compared with standardcare. Six patients were entered into the low dose stage and following review ofthe data, the company has been given clearance by the Data Safety MonitoringBoard to proceed to the higher dose. The FDA has also given notification thatsix patients are adequate for the low dose stage. Earlier Phase I andpre-clinical studies with Trinam(R) have respectively demonstrated the firstever successful adventitial (from outside the blood vessel) gene transfer inhumans and a significant effect in preventing intimal hyperplasia. Trinam(R) is a combination of a Vascular Endothelial Growth Factor (VEGF) genein an adenoviral vector and Ark's biodegradable collagen collar local deliverydevice (EG001). Trinam(R) is placed by the surgeon, at the end of surgery,around the join of the access graft and the vein, where blockages usually occur. The initial target market for Trinam(R) is haemodialysis graft access surgery,a treatment for kidney failure patients in which a plastic tube is graftedbetween blood vessels in the forearm to enable regular blood filtration. In theUS and EU there are an estimated 150,000 cases a year where Trinam(R) might beused. Trinam(R) has been granted Orphan Drug Status by both the FDA and EMEA. Dr Jeff Lawson, Principal Investigator, Duke University Medical Centre,commented: "We are through the first learning curve in using this novel productand the results to date look very interesting. If Trinam(R) is proven to helpprolong the patency of haemodialysis access grafts, it would significantlyimprove the quality of life for these very sick and difficult to managepatients." Dr Nigel Parker, CEO of Ark, commented: "We are pleased to have achieved thisfirst trial milestone for Trinam(R) and we will now press on and enrol thesecond stage of the study. We look forward to presenting the data at the ACSmeeting and are encouraged that the Phase I and main preclinical andbio-distribution studies were also accepted for presentation." For further information, please contact: Ark Therapeutics Group plc 020 7388 7722 Dr Nigel Parker, CEO Financial Dynamics 020 7831 3113 David Yates / Lucy Briggs Notes to editors Ark Therapeutics Group plc Ark is a specialist healthcare group (the "Group"), addressing high value areasof clear unmet medical need. With one marketed product, Kerraboot(R), and threefurther lead products in late stage clinical development: Vitor(TM), Cerepro(TM)and Trinam(R), the Group is transitioning from an R&D focused company to acommercial, revenue generating business. Capitalising on over ten years ofresearch in vascular biology and gene-based medicine, Ark has a broad productportfolio targeted at specific unmet clinical needs within vascular disease,wound care and cancer. These are large and growing markets, where opportunitiesexist for effective new products to generate significant revenues. Cerepro(TM)is on track to becoming one of the world's first commercially available gene-based medicines. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable them to be taken throughdevelopment within the Company'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. 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