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.”
Enquiries
Ark Therapeutics plc Tel: +44 (0)20 7388 7722 Dr Nigel Parker, Chief Executive Officer Martyn Williams, Chief Financial Officer
Financial Dynamics Tel: +44 (0)20 7831 3113 David Yates / Sue Quigley
