The DSMB reviewed safety data from the first dose cohort of 3 patients treated with ReN001. The 1st patient treated in the cohort was assessed at 9 months post-treatment, the second patient at 6 months and the 3rd patient at 3 months.
- No cell-related adverse events have been reported in the clinical trial and data from the laboratory safety tests, neurological examinations and neurofunctional tests conducted thus far indicate that the ReN001 treatment is safe and well-tolerated at the initial dose,
- Although preliminary in nature, these data have also enabled some early progress to be made regarding the secondary objective of the trial, namely the evaluation of appropriate clinical measurements for use in the design of future proof-of-concept clinical trials with ReN001.
The Bottom Line: RENE expects that the next dose cohort of 3 further patients will have been treated by the end of this year assuming no significant recruitment delays. The remaining dose cohorts in the PISCES trial are expected to be treated in 2012, at which point ReNeuron intends to have discussed and agreed its subsequent clinical development strategy for ReN001 with the relevant regulatory authorities both in theUK and beyond. In this PI single administration dose escalation study, the ReN001 stem cell therapy is being administered to a total of 12 stroke patients who have been left disabled by an ischemic stroke. The aim of the study is to test the safety and tolerability of the treatment in progressive doses while evaluating efficacy measures for the design of future clinical trials with ReN001, including structural and functional MRI imaging measures as well as a number of tests of sensory, motor and cognitive functions.