PVG.L Regulatory News (PVG)

23 Aug 2006 07:01

Ark Therapeutics Group PLC23 August 2006 23 August 2006 Ark Therapeutics Group plc Further Positive Phase II Results of Trinam(R) Gene Therapy - Clear evidence of effectiveness in breakthrough treatment for kidney failure patients - - Recruitment complete - Low dose graft data improves to over five times controls - High dose grafts remain open - Ark Therapeutics Group plc ("Ark") today announces further positive results froma Phase II trial of Trinam(R), its novel gene therapy to prevent blood vesselsblocking in kidney dialysis patients who have undergone vascular access graftsurgery. Results of the low dose group were first reported in October 2005.The new data show that the access grafts of low dose patients remain functionalfor dialysis on average over five times longer (17.8 months) than controlpatients in the trial (3.3 months). In the high dose group, recruited after thelow dose group, all patients with successful graft implants still have opengrafts with patency averaging 8 months so far. For the primary end point ofsafety, no systemic distribution of Trinam(R) has been found in either of thehigh or low dose groups and the product is well tolerated. Patients in renal failure depend on effective vascular access for haemodialysis,which removes blood from the body, cleans it and returns it, usually three timesa week. Without dialysis these patients would die. A common method of gainingaccess to the circulatory system is via an artificial blood vessel (vascularaccess graft) surgically implanted between an artery and a vein in the forearm.However, in a majority of patients, the grafts become blocked due to overgrowthof muscle tissue inside the blood vessel (intimal hyperplasia) and this requiresfurther complex surgery to allow dialysis to take place. Trinam(R) is a combination of a vascular endothelial growth factor gene in anadenoviral vector (Ad-VEGF-D) and Ark's biodegradable local delivery collagencollar device (EG001). At the end of the access graft surgery procedure, thecollar is fitted around the outside of the vein/graft join. The Ad-VEGF-Dsolution, which reduces the likelihood of blood clots and intimal hyperplasia,is then injected into the space between the wall of the collar and the bloodvessel. This unique method of administration of the gene localises its deliveryto the target tissue site, maximising efficacy, avoiding systemic distributionand thus minimising the potential for side effects. The Phase II trial of Trinam(R) is an ongoing open-label, standard carecontrolled clinical trial that primarily assesses safety, with efficacy as asecondary measure. Of the 16 patients included in the study, six were assignedto a low dose group (one dose of VEGF 4 x109 viral particles) delivered at thetime they underwent surgery either to implant a first vascular access graft orto insert a new graft in a different location after failure of a previous accessprocedure), six to a high dose group (4 x 1010 viral particles), and theremaining four to a control group receiving standard care only. One operationalfailure occurred in each of the low and high dose groups. After up to two years of follow-up, none of the patients receiving Trinam(R) ineither of the high or low dose groups exhibited serious side effects, other thanthose consistent with the nature of the operation and condition. In addition nosystemic distribution of Trinam(R) was evident. The Ad-VEGF D was not detectedoutside the specific vein area treated by the surgeon, confirming theeffectiveness of the EG001 delivery device. In the low dose group, average patency has now increased to 17.8 months, withtwo of the five remaining open (one at 27 months and one at 22 months). Oneother patient recently blocked at 23 months. In the five patients in the highdose group, all grafts remain open and the average patency is 8 months so far.Three of these are now approaching patency of one year and the early indicationsare that the results in the high dose group will confirm those of the low dosegroup. Three of the four patients in the control group have blocked, with oneremaining open at five months. The average patency period of the control groupis currently 3.3 months. In the US, patients in gene therapy studies are tracked for life and the graftpatency data will therefore continue to improve in this ongoing study until allgrafts are blocked. The study is being conducted at Duke University, TheUniversity of Miami and Vascular and Transplant Specialists in Norfolk,Virginia. In the US and Europe, there are an estimated 150,000 cases each year whereTrinam(R) might be used. In patients fitted with haemodialysis access grafts,up to 60% of the grafts block within a year of being inserted and repeat surgeryshows more rapid failure rates(1). There are currently no approved drugtherapies to reduce failure rates of haemodialysis access graft procedures. Theclinical need for an effective treatment is such that the National Institutes ofHealth in the US has highlighted it as a priority requiring a solution in theHealthy People Directive 2010. Commenting on the results, Dr Jeffrey Lawson, Associate Professor of Surgery andPathology at Duke University, North Carolina and lead investigator in the trial,said: "These initial data support the clinical effectiveness of Trinam(R) in dialysispatients. Instead of having the majority of vascular access grafts re-operatedon within a year, if the early results of this trial continue, this treatmentpreserves the graft's functionality for a longer period, so patients can goabout their lives normally and have fewer surgical interventions andcomplications. By delaying the rate of failure of dialysis access grafts, thetreatment may also save healthcare systems some $15,000 to $20,000 for eachintervention. This kind of technology is very exciting and early resultssuggest that it may have a valuable role to play in the treatment of kidneyfailure patients." Nigel Parker, Chief Executive of Ark, added: "The results of this study so far have exceeded the Company's expectations inthis very serious condition and confirm our original enthusiasm for theproduct's potential. Trinam(R) represents a breakthrough in targeted genemedicine and demonstrates Ark's expertise and leadership in this emerging field." (1)Reference: Rosas SE et al, Determinants of successful synthetichaemodialysis vascular access graft placement. J. Vasc. Surg. 2003;37:1036-42. For further information: Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722Dr Nigel Parker, CEOMartyn Williams, CFO Financial Dynamics Tel: +44 (0)20 7831 3113David YatesAnna Keeble 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(TM), 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 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. 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