ARK THERAPEUTICS TO BEGIN STUDY OF CACHEXIA DRUG

Ark Therapeutics announced it has held scientific advice meetings with the FDA and the European Medicines Evaluation Agency regarding its planned Phase III trial of Vitor, an oral therapy in development for treating the weight loss and muscle wasting (cachexia) associated with cancer.

The regulatory agencies reviewed the Vitor data package, including results from the Phase II/III trial completed in 2006 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 optimize the study design and architecture and to commence Phase III clinical development.

Ark said it is possible it could seek 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 finalize the design of the study during the FDA special protocol assessment process.

The Phase III study is planned as a multicenter, randomized, placebo-controlled trial of up to 250 patients, in which the efficacy and safety of Vitor will be investigated in non-small-cell lung cancer patients with cachexia. The study will last for 16 weeks. The rate of weight loss will be measured, as well as key functional and clinically relevant quality-of-life markers. The trial is scheduled to begin in the third quarter, after protocol assessment has been completed.