PVG.L Regulatory News (PVG)

1 Sep 2006 07:00

Ark Therapeutics Group PLC01 September 2006 Ark progresses Cerepro(TM)review with EMEA London, UK, 1 September 2006 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces that it has filed its response to the first series ofquestions raised by the EMEA's scientific committee as part of the marketingauthorisation application (MAA) review process for Cerepro(TM), its novelgene-based medicine for the treatment of operable high grade glioma (braincancer). Ark's response has been filed in accordance with the standardprocedure and time frame. The application for marketing approval was submittedby Ark in the second half of last year and, following validation of thesubmission by the EMEA, was accepted for review in October 2005. To facilitate the response, Ark's Finnish manufacturing facility hasmanufactured the necessary 'conformity' batches of Cerepro(TM) to commercialsupply specifications. The Phase II Cerepro(TM) study, which forms the mainclinical evidence in the submission, has also been subject to a GCP inspectionas a specific part of the MAA review process. In addition, Ark's headquartershas satisfactorily completed a full good clinical practice ("GCP") systeminspection under the new EU pharmaceutical regulations. Cerepro(TM) has completed three clinical studies during its development to date:a Phase I study establishing safety and posology (dosing and method ofadministration) and two safety and efficacy studies. Cerepro(TM) treatmentproduced an average extension of 7.5 months of life, almost doubling survivaltime in a disease where most patients will only live for around eight months. Cerepro(TM) has Orphan Drug Status in Europe and the USA and is the first genemedicine in the world (1) to undergo a formal MAA review. Dr Nigel Parker, CEO of Ark, commented: "This review is significant because itgives clarity to the regulatory requirements and standards that need to be metfor gene-based medicines, a new and exciting class of biological drugs in whichArk is rapidly becoming recognised as a world leader. We continue to makesignificant advances with Cerepro(TM) and look forward to providing furtherupdates on its overall progress in due course." Notes(1) ex-China For further information please contact: Ark Therapeutics Group plc: +44 (0)20 7388 7722Dr David Eckland, Director of Research & Development Financial Dynamics: +44 (0)20 7831 3113David YatesAnna 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. 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 is a specialist healthcare group (the "Group"), addressing high value areasof clear unmet medical need. With one marketed product, Kerraboot(R), and threefurther lead products in late stage clinical development: Vitor(TM), Cerepro(TM)and Trinam(R), the Group is transitioning from an R&D focused company to acommercial, revenue generating business. Capitalising on over ten years ofresearch in vascular biology and gene-based medicine, Ark has a broad productportfolio targeted at specific unmet clinical needs within vascular disease,wound care and cancer. These are large and growing markets, where opportunitiesexist for effective new products to generate significant revenues. Cerepro(TM) is on track to becoming one of the world's first commerciallyavailable gene-based medicines. 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