PVG.L Regulatory News (PVG)

16 Feb 2007 07:00

Ark Therapeutics Group PLC16 February 2007 Positive outcome from pre-Phase III FDA and EMEA scientific advice meetings for VitorTM Phase III trial scheduled to commence in H2 2007 16 February 2007 - Ark Therapeutics Group plc ("Ark" or the "Company") todayannounces that it has held positive pre-Phase III scientific advice meetingswith the US Food and Drug Administration (FDA) and the European MedicinesEvaluation Agency (EMEA) regarding VitorTM, an oral therapy in development fortreating the weight loss and muscle wasting (cachexia) associated with cancer. The regulatory agencies reviewed the VitorTM data package, including resultsfrom the Phase II/III trial completed in 2006 (a first to man study in cachexia)and the Company's proposed Phase III study protocol. Key points to emerge fromthe meetings were that the existing data are sufficient to allow Ark to optimisethe study design and architecture and to commence Phase III clinicaldevelopment. The possibility exists for an approval based either on treatingweight loss or on improving clinically relevant functional measurements such asmuscle strength. VitorTM has been awarded Fast Track status by the FDA and theCompany expects to finalise the design of the study during the FDA SpecialProtocol Assessment (SPA) process. The Phase III study is planned as a multi-centre, randomised, placebo controlledtrial of up to 250 patients, in which the efficacy and safety of VitorTM will beinvestigated in non-small cell lung (NSCL) cancer patients with cachexia. Thestudy will be of 16 weeks in duration. To avoid study entry effects, the firstfour weeks will be a 'lead in' to confirm weight loss is actually occurring inthe entered patients, after which they will be randomised into the study. Therate of weight loss will be measured, as well as key functional and clinicallyrelevant quality of life markers. The study is anticipated to take about 18months to complete and will be conducted in both the USA and Europe. The trialis scheduled to commence in Q3 2007, after protocol assessment has beencompleted. Final protocol details will be announced at that time. Commenting on today's announcement, Dr Nigel Parker, Chief Executive of Ark,said: "The outcome of these latest meetings with the regulatory agencies in the US andEurope is further good news for Ark. We now have three products at the PhaseIII development stage which gives us one of the strongest late stage pipelinesin the small cap biotechnology sector. In addition, it demonstrates thestrategy and value of our business model, spreading risk across a number ofindependent products in development." For further information: Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722Dr Nigel Parker, CEOMartyn Williams, CFO Financial Dynamics Tel: +44 (0)20 7831 3113David YatesAnna Keeble Notes to Editors Vitor 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. Pre-clinical work has shown VitorTM up-rates the ability of mitchondriato produce energy. In addition, by working on the ubiquitin proteasome pathway,it prevents the breakdown of muscle proteins (actin and myosin) and reverses theimpaired muscle protein production, which both occur as a result of the actionof chemicals secreted by the cancer tumour and lead to weight loss. Arkestimates that 1.5 million new cases of cancer cachexia occur every year in theUS and Europe yet few treatment options currently exist. Phase II/III Trial Results As previously announced in January 2006, full results of patients completing thestudy showed treatment with VitorTM significantly (p < 0.028) reduced the rate of cachexia in patients with non-small cell lung and colorectal cancer, but not in patients with pancreatic cancer. The combined analysis of all cancers for the primary endpoint of overall weight loss showed that, whilst treated patientson average lost 29% less weight than untreated patients, the difference did notreach significance (p>0.05%). The statistical results in the primary endpointswere principally confounded by pancreatic cancer patients showing a differentresponse from the other two cancers and a large number (42%) of studynon-completers causing high variability in the data. For the co-primaryendpoint of grip strength across all cancers, VitorTM treatment attenuated meangrip strength by 42% compared with placebo but again the results did not reachstatistical difference. Statistical significance was reached in two secondaryendpoints, extent of fatigue since last visit (p < 0.039) and level of fatigue at the reporting time (p < 0.0072). Patients had lost an average of 15% body weight (av. 24 lbs) in the six monthsprior to entering the study. The rate of weight loss on entering the studyslowed markedly in both treated and untreated groups. It is possible thatbecause patients had lost so much weight prior to entry, they could lose littlemore; however, a 'study entry' effect may have existed. Nevertheless, the trialpopulation lost an average of 2.3lbs during the 12 week period with treatedpatients losing an average of 1.91lbs and controls 2.68lbs. After four weeks inthe study, the beneficial effect of VitorTM on rate of weight change becameevident in all cancer types. Pancreatic cancer patients on VitorTM on averagelost 0.020lbs/day from week 4 to week 12 with controls losing 0.061lbs/day andNSCL and colon cancer patients showed average net weight gains of +0.0025lbs/dayon VitorTM whilst controls lost 0.022lbs/day. The patients who had lost themost weight on study entry appeared to show the greatest response to VitorTM.The safety profile showed VitorTM to be well tolerated and the study did notreveal any unexpected events About Ark 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