The regulatory agencies reviewed the Vitor™ data package, including results from 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 from the meetings were that the existing data are sufficient to allow Ark to optimise the study design and architecture and to commence Phase III clinical development. The possibility exists for an approval based either on treating weight loss or on improving clinically relevant functional measurements such as muscle strength. Vitor™ has been awarded Fast Track status by the FDA and the Company expects to finalise the design of the study during the FDA Special Protocol Assessment (SPA) process.
The Phase III study is planned as a multi-centre, randomised, placebo controlled trial of up to 250 patients, in which the efficacy and safety of Vitor™ will be investigated in non-small cell lung (NSCL) cancer patients with cachexia. The study will be of 16 weeks in duration. To avoid study entry effects, the first four weeks will be a ‘lead in’ to confirm weight loss is actually occurring in the entered patients, after which they will be randomised into the study. The rate of weight loss will be measured, as well as key functional and clinically relevant quality of life markers. The study is anticipated to take about 18 months to complete and will be conducted in both the USA and Europe. The trial is scheduled to commence in Q3 2007, after protocol assessment has been completed. 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 and Europe is further good news for Ark. We now have three products at the Phase III development stage which gives us one of the strongest late stage pipelines in the small cap biotechnology sector. In addition, it demonstrates the strategy and value of our business model, spreading risk across a number of independent products in development.”
For further information:
Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722 Dr Nigel Parker, CEO Martyn Williams, CFO
