PVG.L Regulatory News (PVG)

28 Oct 2005 07:01

Ark Therapeutics Group PLC28 October 2005 Preliminary Results of VitorTM Study Show Clear Therapeutic Effect in Cancer Cachexia 28 October 2005 - Ark Therapeutics Group plc ("Ark") announces today that thepreliminary results of the VitorTM study in 200 patients with cancer cachexiaindicate that the product changes the pattern of weight loss in the three typesof cancer (colorectal, lung and pancreatic) in the study. Patients entering this study were all terminal cancer patients and had alreadylost an average of 15% of their body weight. A positive treatment effect withVitorTM was observed across the treatment group, irrespective of cancer type.Whilst initially continuing to lose weight over the first four weeks of thestudy, colorectal and lung cancer patients then gained weight over the nexteight weeks to study end (week 12) whereas placebo patients lost weight (VitorTMdaily rate of change +0.025lbs vs placebo -0.022lbs). Pancreatic cancerpatients (the more aggressive of the cancers studied), whilst not gaining weightafter the first four weeks of the study, exhibited a marked reduction in thedaily rate of weight loss compared with placebo (VitorTM -0.02lbs per day vsplacebo -0.06lbs per day) over the remainder of the study. The positive effectsof VitorTM treatment were also evident in the initial analysis of hand gripstrength. The initial results from this study, which is the first time VitorTM has beentested in humans in this disease, demonstrate a proof of principle in humansconsistent with that previously found in pre-clinical models and the novel modeof action reported in late 2004. Professor John Martin, Chief Scientific Officer at Ark, said: "The positiveeffects observed in this study of VitorTM would offer cancer patients a veryrelevant clinical benefit as weight loss and the associated weakness are some ofthe most distressing and dangerous aspects of late stage cancer." Nigel Parker, Chief Executive Officer, said "This first data cut looks veryinteresting and we look forward to completing the full study analysis todetermine what further activities may be required for regulatory filing. Thishas been a tremendous two weeks at Ark. With Trinam(R)'s low dose resultsshowing a tripling of haemodialysis access graft patency, our Finnishmanufacturing facility receiving the world's first(1) licence to produce a genemedicine for commercial supply, the EMEA accepting the CereproTM marketingauthorisation application for review and finally these first proof of principleVitorTM results, we have ended this intense period of newsflow in exceptionalshape." 1 Outside China A conference call for analysts will be held today at 09.00am BST. For dial indetails please contact Mo Noonan on 0044 (0)207 269 7116. For further information, please contact: Ark Therapeutics Group plc 020 7388 7722 Dr Nigel Parker, CEO Martyn Williams, CFO Financial Dynamics 020 7831 3113 David Yates Davina Langdale 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 an emerging healthcare group (the "Group") now entering thecommercialisation phase, with one product introduced into hospitals and threefurther lead products in late stage clinical development. Capitalising on overten years of research in vascular biology and gene-based medicine, Ark has abalanced portfolio of proprietary healthcare products targeted at specific unmetclinical needs within vascular disease and cancer. These are large and growingmarkets, where opportunities exist for effective new products to generatesignificant revenues. Ark's products are sourced from related but largely non-dependent technologieswithin the Group and have been selected to enable Ark to take each productthrough development and to benefit from Orphan Drug Status and/or Fast TrackDesignation, as appropriate. The Group generally retains ownership of itsproduct candidates throughout clinical development. Ark has secured patents orhas patent applications pending for all its lead products in principalpharmaceutical markets and retains the right to market its lead products in thekey North American and European markets. 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 successfully listed through an initial public offering on theLondon 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