The treatment of the patient follows recommendation from an independent Data Safety Monitoring Board (DSMB) to advance the investigation of a higher dose of ReN001, based on its review of the safety data from the first dose cohort of three patients treated with ReN001.
The remaining dose cohorts in the Pisces trial are expected to be treated by 2012, at which point ReNeuron plans to have discussed and agreed its subsequent clinical development strategy for ReN001 with the relevant regulatory authorities both in the UK and beyond.
The study aims to test the tolerability and safety of the treatment in progressive doses while investigating efficacy measures for the design of future clinical trials with ReN001.