PVG.L Regulatory News (PVG)

23 Jul 2007 07:01

Ark Therapeutics Group PLC23 July 2007 Ark Therapeutics Group plc Ark Therapeutics closes early Cerepro(TM) approval application following confirmation from EMEA that data from ongoing Phase III trial are needed for approval Cerepro(TM) Phase III trial continues on schedule 23 July 2007: Ark Therapeutics PLC ("Ark" or the "Company") announces today thatit has informed the European Medicines Agency ("EMEA") that it would no longercontinue to progress its application for early marketing approval of Cerepro(TM),its treatment for malignant glioma, under the exceptional circumstances route,following confirmation from the Agency that data from the ongoing Phase IIItrial are required for approval. Ark has consequently withdrawn the applicationas the final procedural step to conclude the early approval process. Ark Therapeutics confirms that progress with Cerepro(TM) remains firmly onschedule, with a filing for marketing approval anticipated, as previouslyindicated, in 2008 following the conclusion of the ongoing, fully-recruitedPhase III study. The Company looks forward to providing further timely updateson the progress of its Phase III study. 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. Cerepro(TM) Cerepro(TM) 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, Cerepro(TM) 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: CereproT(TM), Vitor(TM), and Trinam(R), the Group is transitioning from an R&D company to a commercial, revenue generating 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 and developmentprogrammes. 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