PVG.L Regulatory News (PVG)

30 May 2008 07:00



Ark Commences Vitor Pilot Phase III Clinical Programme 

30 May 2008 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces that the UK and Hungarian authorities have given Clinical Trials and Centralised Ethics Committee approvals to allow the Company to commence the Pilot Phase III trial (Study 208) with Vitor, Ark's product to treat cachexia (involuntary muscle wasting) associated with cancer.

Study 208 is a blinded, randomised, placebo controlled, multicentre trial in up to 64 patients. Recruitment is planned in five countries in Europe. The trial will study the effect of Vitor on patients with non-small cell lung cancer who are already experiencing clinical signs of cachexia. Patients will be assessed for their rate of muscle wasting during an initial blinded study run-in period of up to 6 weeks, and thereafter randomised to active or control treatment for a further 12 week period. Total weight loss, lean body mass and other physical markers of cachexia will be assessed using a variety of methodologies. The study results will provide data to support the design of the final Phase III programme.

Vitor has been awarded Fast Track Status by the FDA reflecting the high clinical need for an effective product to treat cachexia, which affects up to 70% of patients with solid tumours and is the most frequently reported cause of death in these patients. A Special Protocol Assessment (SPA) process was opened with the FDA in 2007. The Company is expected to enter full Phase III development in 2009 following completion of this pilot study. 

A Phase II/III study of Vitor in 165 patients has already been completed in the USA and Europe, where treatment showed a significant effect compared with placebo in reducing the rate of daily weight loss in patients with small cell lung and colon cancer.

Nigel Parker, CEO at Ark, commented: "The development of medicinal products is a complex and difficult process, with requirements from the regulators increasing every year. We are therefore pleased to report that we have succeeded in meeting the latest regulatory requirements and have received approvals to allow this important trial to commence."

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Notes to Editors

Vitor and cachexia in cancer

Vitor™ is an oral small molecule therapy for the treatment of muscle wasting (cachexia), a secondary, often fatal, condition commonly seen in patients with cancer. The active ingredient was originally developed as a treatment for high blood pressure and is currently marketed in Japan and certain countries in Europe. Pre-clinical work has shown Vitor™ up-rates the ability of mitchondria to produce energy. In addition, by working on the ubiquitin proteasome pathway, it prevents the breakdown of muscle proteins (actin and myosin) and reverses the impaired muscle protein production, which both occur as a result of the action of chemicals secreted by the cancer tumour and lead to weight loss. Ark estimates that 1.5 million new cases of cancer cachexia occur every year in the US and Europe yet few treatment options currently exist.

Ark Therapeutics Group plc

Ark Therapeutics Group plc is a specialist healthcare group (the "Group") addressing high value areas of unmet medical need within vascular disease, wound care and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues. With four marketed devices, Kerraboot®, Kerraped®, Flaminal® and Neuropad®, and three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam®, the Group is transitioning from an R&D company to a commercial, revenue generating business.

Ark's own products are sourced from related but largely non-dependent technologies within the Group and have been selected to enable them to be taken through development within the Group's own means and to benefit from Orphan Drug Status and/or Fast Track Designation, as appropriate. This strategy has allowed the Group to retain greater value and greater control of clinical development timelines, and to mitigate the risks of dependency on any one particular programme or development partner. Ark has secured patents or has patent applications pending for all its lead products in principal pharmaceutical markets. 

Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Mr Stephen Barker of University College London and Professor Seppo Yla-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland, all of whom play leading roles in the Company's research and development 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 all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.