FDAnews
www.fdanews.com/articles/98263-cenes-ergomed-begin-recruitment-for-phase-ii-trial-of-cns-5161

CeNeS, Ergomed Begin Recruitment for Phase II trial of CNS 5161

September 10, 2007

CeNeS Pharmaceuticals and the Ergomed Group announced that they have initiated recruitment into a Phase II study of CNS 5161, a potential new pain drug.

The Phase II dose-escalation study is designed to establish the optimal schedule for infusion of CNS 5161 in the management of cancer pain. The aim of the study is to identify the maximum tolerated dose and analgesic efficacy of CNS 5161 in this patient population, CeNeS and Ergomed said.

A maximum of 36 subjects will be enrolled sequentially and receive intravenous infusions of CNS 5161 administered at four-hour intervals at increasing dose levels. The companies plan to have results in 2008.