PVG.L Regulatory News (PVG)

27 Apr 2007 07:01

Ark Therapeutics Group PLC27 April 2007 Ark Therapeutics Group plc EMEA decision on CereproTM Phase II filing 27 April 2007, London UK: Ark Therapeutics Group plc ("Ark" or the "Company")today announces that it has been informed by the European medicines regulatoryauthority, the EMEA, that in their opinion marketing approval cannot yet begiven for CereproTM, Ark's novel gene-based medicine for the treatment ofoperable high grade glioma (malignant brain tumour). Although detailed feedbackhas yet to be received from the EMEA, it is understood that the EMEA takes theview that there is not yet a sufficient weight of clinical evidence from thelimited number of patients included in the Phase II data to conclude that therisk benefit for patients has been proven beyond doubt. The CereproTM filing has determined the regulatory pathway and standards forapproval of gene-based medicine in Europe and CereproTM appears to have clearedall the historically problematic technical issues, including the Chemistry andManufacturing Controls (CMC), Preclinical and Environmental sections of theapproval process. Only the nature and extent of the clinical data now appearsoutstanding. Overall this success represents one of the most significantadvances for many years in this breakthrough area of biomedicine. Ark will be examining the EMEA's detailed feedback relating to the outstandingconcerns, when received, before deciding how to progress the regulatory approvalprocess. These concerns may be able to be resolved through the provision offurther data or analyses from the existing Phase II trials or new data may berequired from the larger ongoing Phase III study (Study 904), which has recentlycompleted recruitment on schedule. Study 904 is being conducted as part of Ark's existing business plan and is astandard care-controlled trial to assess the efficacy and safety of CereproTM in250 patients with high grade glioma. Patients are randomised in a 1:1 ratio,either to standard care alone, or to standard care plus CereproTM and patientsare blinded to the point of treatment allocation. The multi-centre study isbeing conducted in Europe and Israel. CereproTM has Orphan Drug Status in Europe and the USA. It is manufactured byArk in its facility in Finland, the first facility ever to be approved tomanufacture gene-based medicines for commercial supply in Europe. The Phase IIclinical trials completed to date have shown that CereproTM treatment producesan average extension of 7.5 months of life, giving around 15.5 months survivalcompared to the standard care group, which survived around 8 months. Nigel Parker, Chief Executive of Ark, commented: "CereproTM was filed early as an Orphan Drug because it has shown significantpatient benefit in both of its Phase II trials. Early approval would have beenwelcome upside news but the major successes in clearing manufacturing,preclinical and environmental sections of the filing are huge regulatory stepsforward for CereproTM and for the prospects of gene-based medicines in Europe.Enthusiasm for CereproTM is illustrated by the rapid rate of recruitment intoour Phase III study and we will continue to develop the product according toplan, with the goal of making it commercially available to glioma patients assoon as possible." For further information please contact: Ark Therapeutics +44 (0)20 7388 7722Dr Nigel Parker, Chief Executive OfficerMartyn Williams, Chief Financial Officer Financial Dynamics +44 (0)20 7831 3113David Yates / Anna Keeble Notes to Editors Malignant glioma Malignant glioma is a devastating and fatal form of brain tumour that is usuallyconfined to the brain. The current standard therapy involves surgicallyremoving the solid tumour mass (when possible) and initiating radiotherapy and/or chemotherapy. Even with the latest approved treatments, most patients diewithin one year of diagnosis. Little therapeutic progress has been made inrecent years and the prognosis for malignant glioma patients is poor. A highunmet clinical need exists for new treatments that prolong life in thisdevastating disease. There are approximately 16,000 cases of malignant glioma inthe EU per annum which are operable. CereproTM CereproTM is an adenoviral mediated gene based medicine (ad.HSV tk) given bymultiple injections into the healthy brain tissue of patients following surgicalremoval of the solid tumour mass. In the following days, ganciclovir, is givenintravenously. Once treated, healthy brain cells surrounding the site where thetumour was removed express the enzyme thymidine kinase. This converts theganciclovir to a substance which specifically kills dividing cells. The healthyneurones surrounding the tumour in the brain are non-dividing and are thereforenot susceptible to this substance. In this way, CereproTM harnesses healthybrain cells to help prevent a new tumour from growing. 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 Exchange