22nd May 2007 07:01
Ark Therapeutics Group PLC22 May 2007 Ark Therapeutics Group plc US Recombinant DNA Advisory Committee gives early clearance for Trinam(R) Phase III trial 22 May 2007, London, UK: Ark Therapeutics Group plc announces today that it hasbeen given clearance by the US Recombinant DNA Advisory Committee (RAC) for itsplanned Phase III US clinical study of Trinam(R), Ark's novel gene-based therapyto prevent haemodialysis access graft blockage. Ark filed its application to the RAC earlier this month and a final decision hadbeen expected by the end of the RAC's public review process scheduled for 19-21June. After the initial review, the RAC members have determined that theapplication does not require further review and discussion in a public sessionand has therefore given clearance for the product to commence the 200+ patientpivotal Phase III study. The Company will now undergo Special ProtocolAssessment (SPA) for the Phase III study with the FDA and the trial is expectedto commence in the second half of 2007 once this is complete. Commenting on the announcement Ark's CEO, Dr Nigel Parker, said: "The rapid granting of this approval without the need for a public hearingillustrates just how far gene-based medicine has advanced in the last year ortwo. We look forward to giving further updates on the SPA process in duecourse." 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 Trinam(R) 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. Trinam(R) has undergone a Phase II clinical study, which has shown encouragingearly efficacy results, with grafts of treated patients remaining functional fordialysis on average between two and four times longer than controls. For theprimary end point of safety, no quantifiable systemic distribution of Trinam(R)was found and the product is well tolerated. No serious side effects wereexhibited other than those consistent with the nature of the operation andcondition. After consultation with the FDA in January 2007, Ark announced that it intendedto undertake a small pre-clinical study on Trinam(R), investigatingbiodistribution in an "end-to-side" procedure for surgical placement of thegraft. If the results of this study are in line with expectations, it willallow the Phase III trial to include this procedure alongside the "end-to-end"placement procedure. Pending SPA agreement, the Phase III study is expected tocommence around mid-2007 and to last for approximately 18 months. 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) in addition to standard care or standard care alone atthe time of surgical placement of a synthetic PTFE graft for vascular access.The primary endpoint of the trial will be the time to graft failure. Recombinant DNA Advisory Committee The US National Institutes of Health (NIH) established the RAC on October 7,1974 in response to public concerns regarding the safety of manipulating geneticmaterial through the use of recombinant DNA techniques. Although the RAC'smembership and responsibilities have evolved over time with scientificunderstanding and developments in this technology, it continues to serve theNIH, as well as the scientific and lay publics, as a critically important forumfor open, public deliberation on the panoply of scientific, ethical, and legalissues raised by recombinant DNA technology and its basic and clinical researchapplications. Over the course of the Committee's existence, transparency andaccess have been its defining characteristics, enabling public acceptance of acritically important technology and creating an environment in which science canadvance in an informed, safe, and ethical manner. The RAC comprises experts in a wide range of scientific and medical disciplinesand also includes ethicists and members of patient and other lay communities.Because of the dedication, effort, and thoughtful contributions of its membersover the past 30 years, the RAC has been a vital national forum promotingcritically important scientific progress in a transparent, responsible, and safemanner and enhancing public trust in the science. Ark Therapeutics Group plc 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 own 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 ExchangeRelated Shares:
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