Ark’s Vitor commences patient enrolment into Phase III pilot study
LONDON, 27 August 2008: Ark Therapeutics Group plc (“Ark” or the “Company”) today nnounces that enrolment of patients into its Phase III pilot study for VitorTM (Study 208) has commenced. VitorTM is 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 being conducted in five countries in Europe. The trial will study the effect of VitorTM 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.
VitorTM 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 VitorTM 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 of Ark, commented: “Having secured approvals from all the various committees in the countries involved in the trial, we are pleased to report this clinical progress on VitorTM with patients entering the trial as expected. We look forward to providing an update on the trial’s progress in due course.”
Ark Therapeutics Group 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
Posted: August 2008