PVG.L Regulatory News (PVG)

25 Oct 2007 07:01

Ark Therapeutics Group PLC25 October 2007 Ark to conduct pilot Phase III for Vitorto finalise SPA 25 October 2007, London, UK - Ark Therapeutics Group plc ("Ark" or the "Company") today provides an update on the Special Protocol Assessment (SPA)process with the FDA relating to the Phase III programme for VitorTM, itsproduct for weight loss and muscle wasting (cachexia) associated with cancer. An SPA is a written agreement between the trial's sponsor and the FDA regardingthe design, endpoints and planned conduct and analysis of a trial to be used insupport of regulatory approval. It therefore provides greater clarity andcertainty that, if the trial's endpoints are met, approval from the FDA will beforthcoming. In finalising the SPA process, discussions with the FDA have focused on trialarchitecture and endpoints. Because there are a number of endpoints by whichcachexia can be measured, it has been agreed that some modifications to theprotocol and endpoints need to be made, amending the design used in the trialalready conducted. In order to ensure that the right endpoints are chosen andthe Phase III protocol can be implemented, Ark intends to conduct a small (60patient) pilot Phase III study which will provide the necessary data to confirmthe design of the full Phase III programme. This trial will commenceimmediately and is expected to take approximately nine months, but is expectedto result in a faster review process on completion of clinical development. Commenting on the announcement, Nigel Parker, CEO of Ark, said: "The FDA's requirements for relevant clinical endpoints and safety data in PhaseIII studies have become increasingly rigorous and the SPA process has beenextremely useful in understanding exactly what is required for approval beforeincurring the expenditure and time associated with a full Phase III trial. Inthis environment, it is appropriate, even for products like Vitorwhich hasbeen awarded Fast Track designation, to be adopting a careful approach to ensurethat there are no outstanding trial design or endpoint issues which mightprevent an approval in the future." For further information: Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722 Dr Nigel Parker, CEO Martyn Williams, CFO Financial Dynamics Tel: +44 (0)20 7831 3113 David Yates Lara Mott Notes to Editors Vitor and cachexia in cancer Vitoris 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 Vitorup-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 Vitorsignificantly (p0.05%). 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, Vitortreatment 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