PVG.L Regulatory News (PVG)

5 Jan 2007 07:53

Ark Therapeutics Group PLC05 January 2007 CereproTM Phase III Trial Progress Update Patient Recruitment on Track and Positive Outcome from Latest Independent Data and Safety Monitoring Board Review January 5 2007 - Ark Therapeutics Group plc (LSE: AKT) ("Ark" or the "Company)today provides an update on the Phase III trial (Study 904) being undertaken onits lead product, CereproTM, for the treatment of high grade glioma (malignantbrain tumour). The independent Data and Safety Monitoring Board (DSMB) met on December 13th2006 to review the data from the first 130 patients entered into the trial. Arkhas now been notified by the DSMB that the side effect profile observed to datein Study 904 is in line with that previously reported, giving the DSMB no causefor concern nor requiring any alteration in the design and architecture of thetrial. The DSMB has unanimously recommended that the Company continue the studywithout modification. Recruitment into Study 904 has now passed 160 patients, in line with theCompany's previous guidance. Study 904 is a standard care controlled study to assess the efficacy and safetyof CereproTM in up to 250 patients with high grade glioma. Patients arerandomised in a 1:1 ratio either to standard care alone, or to standard careplus CereproTM treatment and patients are blinded to the point of treatmentallocation. The multi-centre study is being conducted in Europe and Israel. Trials completed to date have shown that CereproTM treatment produces an averageextension of 7.5 months of life, giving around 15.5 months survival in a diseasewhere most patients will only live for around 8 months. CereproTM is currently undergoing regulatory review for marketing approval withthe European regulatory authority, the EMEA, and the Company expects the reviewto be completed around the end of March 2007. CereproTM is the first gene-basedmedicine1 to undergo full regulatory review. The product is manufactured by Ark at its cGMP facility in Finland, which wasgranted the first ever commercial gene therapy production licence1 in late 2005. Dr David Eckland, Head of Research and Development at Ark, said: "This is verysolid progress, both in terms of patient recruitment into the trial and with thepositive outcome of this latest data review by the DSMB. The fact thatCereproTM is showing a consistent safety profile is further confirmation thatthe commercial production and quality standards we have established in Finlandare delivering a reliable and predictable product." 1 Outside China For further information please contact: Ark Therapeutics Group plc: +44 (0)20 7388 7722 Dr Nigel Parker, CEO Martyn Williams, CFO Financial Dynamics: +44 (0)20 7831 3113 David Yates Anna Keeble Notes to Editors High grade glioma High grade glioma (malignant glioma) is a devastating and fatal form of tumourthat is usually confined to the brain. The current standard therapy involvessurgically removing the solid tumour mass (when possible) and initiatingradiotherapy and/or chemotherapy. Even with the latest approved treatments,most patients die within one year of diagnosis, with average survival beingabout eight months. Little therapeutic progress has been made in recent yearsand the prognosis for malignant glioma patients is poor. A high unmet clinicalneed exists for new treatments that prolong life in this devastating disease. Itis estimated that there are approximately 16,000 cases of malignant glioma inthe EU 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 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