Ph III US trial of Ark's Vitor cleared by FDA

UK-based Ark Therapeutics says it has held positive preliminary Phase III scientific advice meetings with the US Food and Drug Administration and the European Medicines Agency (EMEA) regarding Vitor (imadapril), its oral drug for the treatment of weight loss and muscle wasting (cachexia) associated with cancer.

The regulatory agencies reviewed the the agent's 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. Furthermore, the firm heard that the possibility exists for an approval based either on treating weight loss or on improving clinically-relevant functional measurements such as muscle strength. The multicenter, randomized, placebo-controlled, 16-week, 250-patient trial will asses safety and efficacy in non-small cell lung cancer patients with cachexia and data are expected in second-quarter 2009. Evolution Securities analyst Jonathan Senior says the Vitor program is "highly speculative." In a note to investors he said that, because of a lack of conclusive data, Vitor does not figure in his valuation model of Ark.