PVG.L Regulatory News (PVG)

24 Apr 2007 07:01

Ark Therapeutics Group PLC24 April 2007 Ark Therapeutics Group plc Phase III CereproTM Study Completes Recruitment 24 April 2007, London UK: Ark Therapeutics Group plc ("Ark" or the "Company")today announces that it has completed recruitment into the Phase III trial(Study 904) for CereproTM, its novel gene-based medicine for the treatment ofoperable high grade glioma (malignant brain tumour). Study 904 is a standard care-controlled study to assess the efficacy and safetyof CereproTM in 250 patients with high grade glioma. Patients are randomised ina 1:1 ratio, either to standard care alone, or to standard care plus CereproTMand patients are blinded to the point of treatment allocation. The multi-centrestudy is being conducted in Europe and Israel. Clinical trials completed to date have shown that CereproTM treatment producesan average extension of 7.5 months of life, giving around 15.5 months survivalin a disease where most patients will only live for around 8 months. 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. CereproTM is currently undergoing regulatory review for early marketing approvalwith the European regulatory authority (EMEA), based on the data from alreadycompleted Phase II trials. The Company expects the review to be completedshortly. Nigel Parker, Chief Executive of Ark, commented: "Completion of recruitment into this Phase III study is a key milestone forCereproTM and we are pleased to report this news according to plan. Theincreasingly rapid recruitment into this trial has been very encouraging andreflects the enthusiasm amongst neurosurgeons for this much-needed product andthe growing appeal of gene-based therapies. CereproTM has previouslydemonstrated that it is able almost to double average patient survival timeoffering significant hope to patients who develop malignant glioma. It is alsothe first gene-based medicine1 to undergo full regulatory review and we lookforward to updating investors on the outcome of the EMEA's review in the nearfuture." Note 1: outside China For further information please contact: Ark Therapeutics +44 (0)20 7388 7722 Dr Nigel Parker, Chief Executive Officer Martyn Williams, Chief Financial Officer Financial Dynamics +44 (0)20 7831 3113 David 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, with average survival being about eight months.Little therapeutic progress has been made in recent years and the prognosis formalignant glioma patients is poor. A high unmet clinical need exists for newtreatments that prolong life in this devastating disease. There areapproximately 16,000 cases of malignant glioma in the EU per annum which areoperable. 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