PVG.L Regulatory News (PVG)

18 Oct 2005 07:00

Ark Therapeutics Group PLC18 October 2005 18 October 2005 Ark Therapeutics Group plc Positive Results of Trinam(R) Gene Therapy Presented at American College of Surgeons Congress - Breakthrough treatment for kidney failure patients - - Access grafts remain functional three times longer than previous procedures- Ark Therapeutics Group plc ("Ark") today announces the publication of positiveresults from an ongoing Phase II trial of Trinam(R), its novel gene therapy toprevent blood vessels blocking in kidney dialysis patients who have undergonevascular access graft surgery. The data to date, which will be presented latertoday at the 2005 Annual Clinical Congress of the American College of Surgeonsin San Francisco, show that access grafts continue to remain functional threetimes longer than previous procedures, with no systemic distribution of theinserted gene being found. Patients in renal failure depend on good vascular access for haemodialysis,which removes blood from the body, cleans it and returns it, three times a week. Without dialysis these patients would die. A common method of gaining accessto the circulatory system is via an artificial blood vessel (vascular accessgraft) sewn between an artery and a vein in the forearm. However, in a majorityof patients, the grafts become blocked due to overgrowth of muscle tissue insidethe blood vessel (intimal hyperplasia) and this requires further complex surgeryto 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 VEGF genesolution, 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, standardcare-controlled clinical trial that primarily assesses safety, with efficacy asa secondary measure. In the study, six patients with end-stage renal diseasedependent on regular haemodialysis for kidney function received one dose of 4 x10 (9) particles at the time they underwent surgery either to implant a firstvascular access graft or to insert a new graft in a different location afterfailure of a previous access procedure. After as long as a year of follow-up, none of the patients exhibited seriousside effects, other than those consistent with the nature of the operation andcondition and no systemic distribution of Trinam(R) was evident. The VEGF genewas not detected outside the specific vein area treated by the surgeon. Whilstone patient had to be withdrawn from the trial because of an infection believedto have been contracted at the time of surgery, the remaining five patients hadencouraging prolonged graft patency. Four patients ongoing in the trial hadpreviously had multiple failed access procedures prior to the trial. The meanpatency of previous access procedures in these patients was 4.5 months. UsingTrinam(R), the mean patency has been extended so far to 14 months and in all ofthese patients the grafts continue to remain patent and functional for dialysis. The study remains ongoing with a higher dose of VEGF (4 x 10 (10)) particles andis being conducted at Duke University, The University of Miami and Vascular andTransplant 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: "Instead of having the majority of vascular access grafts re-operated on withina year, sometimes each two or three times, this treatment preserves the graft'sfunctionality for a longer period, so patients can go about their lives normallyand have fewer surgical interventions and complications. By delaying the rateof failure of dialysis access grafts, the treatment may also save healthcaresystems some $15,000 to $20,000 for each intervention. This kind of technologyis very exciting and some day will be in general use." Nigel Parker, Chief Executive of Ark, added: "These are extremely encouraging results, representing a breakthrough intargeted gene medicine and demonstrating Ark's expertise and leadership in thisemerging field. We had planned to establish primarily safety and systemicdistribution in this low dose group and to get human proof-of-principle resultsof this magnitude exceeds our expectation. We are particularly pleased to seethat patients' grafts continue to remain open after a period far beyond whatmight be expected. If validated during the remainder of the developmentprogramme, Trinam(R) has the potential to save many lives, to bring substantialimprovement to the quality of life of chronic renal failure patients undergoinghaemodialysis, and to save significant healthcare costs." (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 YatesDavina Langdale Notes to Editors Ark Therapeutics Group plc Ark is an emerging healthcare group (the "Group") entering the commercialisationphase, with one product introduced into hospitals and three 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 within vascular disease and cancer. These are large and growing markets,where opportunities exist for effective new products to generate significantrevenues. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable the Company to take eachproduct through development and to benefit from Orphan Drug Status and/or FastTrack Designation, 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 in thekey North American and European markets. 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. 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