PVG.L Regulatory News (PVG)

11 Jan 2007 07:01

Ark Therapeutics Group PLC11 January 2007 Ark Holds Positive End of Phase II Meeting with FDA on Trinam(R) Gene Therapy Phase II data accepted and FDA offers Special Protocol Assessment for singlepivotal Phase III study 11 January 2007 - Ark Therapeutics Group plc ("Ark") today announces that it hasheld a positive "end of Phase II" meeting with the US Food and DrugAdministration ("FDA") regarding Trinam(R), its novel gene therapy to preventblood vessels blocking in kidney dialysis patients who have undergone vascularaccess graft surgery. Key points to emerge from the meeting were that the FDA has agreed that the datafrom the Phase II trial, reported by Ark in August 2006, are sufficient to allowprogression to Phase III and a single Phase III trial will be acceptable for thebasis of a marketing approval. Furthermore, the FDA has offered SpecialProtocol Assessment (SPA) for the single pivotal Phase III study for Trinam(R).The SPA procedure allows Ark to work directly with the FDA to ensure the designof the trial, the definitive clinical objectives and data analyses are optimisedto support regulatory approval. The Phase III study is being planned as a multi-centre, randomised, controlledtrial of up to 250 patients in which the efficacy and safety of Trinam(R) willbe investigated in patients with end stage renal disease (ESRD) requiringvascular access for haemodialysis. Patients with ESRD will be randomised toreceive either Trinam(R) 4x1010 viral particles in addition to standard care orstandard care alone at the time of surgical placement of a synthetic PTFE graftfor vascular access. The primary endpoint of the trial will be the time to graftfailure. Ark reported the preliminary results of the ongoing, open-label, standard-carecontrolled Phase II trial in August, with the new data from the trial showingthat the access grafts of low dose patients remained functional for dialysis onaverage over five times longer (17.8 months) than control patients in the trial(3.3 months). At that time, in the high dose group, recruited after the lowdose group, all patients with successful graft implants had open grafts withpatency averaging 8 months. For the primary end point of safety, noquantifiable systemic distribution of Trinam(R) was found in either of the highor low dose groups and the product is well tolerated. No serious side effectswere exhibited other than those consistent with the nature of the operation andcondition. As part of the overall Trinam(R) programme, Ark also announces today that, afterconsultation with the FDA, it intends to undertake a small pre-clinical study onTrinam(R), investigating biodistribution in an "end-to-side" procedure forsurgical placement of the graft. If the results of this trial are in line withexpectations, it will allow the Phase III trial to include this procedurealongside the "end-to-end" placement procedure. Pending SPA agreement, thePhase III study is expected to commence around mid-2007 and to last forapproximately 18 months. Commenting on today's announcement, Dr Nigel Parker, Chief Executive of Ark,said: "The FDA's positive response to the next stage of Trinam(R)'s development,particularly its offer of Special Protocol Assessment, confirms our belief inthe future of this product. We have very encouraging Phase II data on theclinical effectiveness of Trinam(R) and believe that Trinam(R) may have avaluable role to play in the treatment of kidney failure patients where theproblem of vascular access blocking is identified in the US Healthy People 2010Framework as one of the key medical issues to be resolved. This outcome is inline with our budgeted plan and we look forward to giving a further update afterreceiving Special Protocol Assessment and to the commencement of the Phase IIIstudy." 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 About Trinam(R) and Renal FailurePatients 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. 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. The clinical need for an effective treatment is such that the National Institutes of Health in the US has highlighted it as a priority requiring a solution in the Healthy People Directive 2010. (1) Reference: Rosas SE et al, Determinants of successful synthetichaemodialysis vascular access graft placement. J. Vasc. Surg. 2003;37:1036-42. About Ark 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