PVG.L Regulatory News (PVG)

21 Jun 2005 07:00

Ark Therapeutics Group PLC21 June 2005 Ark completes patient enrolment for VitorTM Phase III study in cancer cachexia London, UK, 21 June 2005: Ark Therapeutics Group plc ("Ark" and the "Company"),the specialist healthcare group, today announces that patient enrolment for thePhase III study of VitorTM, for the treatment of muscle wasting in cancer(cachexia), has been completed. The company expects preliminary results to beavailable towards the end of 2005. The Phase III study is a blinded, placebo controlled, three month study inpatients with solid tumours (colon, pancreas, non small cell lung) exhibitingclinical cachexia, defined as involuntary loss of 5% or more of body weight.Ark originally planned to recruit around 160 patients. However a final review bythe steering committee found 'in trial' cancer deaths, unrelated to the study,were greater than the original estimate had planned for. The Company thereforeextended enrolment to 200 patients to adjust for this. The study is beingconducted in North America and Europe. VitorTM is an oral therapy being developed for the treatment of cachexia (musclewasting) in cancer, a secondary, often fatal, condition commonly seen inpatients with cancer. Between 40 to 90 percent of all cancer patients withsolid tumours experience cachexia, and it is particularly prevalent in thecommon cancers such a lung, stomach and colon cancer. It is estimated thatthere will be over three million new cases of cancer in Europe and the US in2005 of which a large majority will involve solid tumours. There are nopharmaceutical products currently approved specifically for the treatment ofmuscle wasting in cancer and VitorTM has been awarded Fast Track Designation bythe FDA. Dr. David Eckland, Research and Development Director at Ark, commented: "We arepleased with the progress of the Phase III programme for VitorTM and with theway recruitment has been finalised with the protocol extension. We look forwardto seeing the preliminary results towards the end of the year." For further information, please contact: Ark Therapeutics Group plc 020 7388 7722Dr Nigel Parker, CEO Financial Dynamics 020 7831 3113Lucy Briggs Notes to Editors VitorTM and cachexia in cancer VitorTM is an oral small molecule therapy for the treatment of muscle wasting(cachexia), a secondary, often fatal, condition commonly seen in patients withcancer. The active ingredient was originally developed as a treatment for highblood pressure and is currently marketed in Japan and certain countries inEurope. VitorTM has been shown to up-rate the ability of mitchondria to produceenergy. In addition by working on the ubiquitin proteasome pathway, it preventsthe breakdown of muscle proteins (actin and myosin) and reverses the impairedmuscle protein production, which both occur as a result of the action ofchemicals secreted by the cancer tumour and lead to the weight loss. 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: VitorTM, CereproTM andTrinamTM, 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. CereproTM ison track to becoming one of the world's first commercially available gene-basedmedicines. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable them to be taken throughdevelopment within the Company'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. 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. Theseforwardlooking 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, prospective investors arecautioned not to rely on any forward-looking statement. This information is provided by RNS The company news service from the London Stock Exchange