ReNeuron receives DSMB clearance to progress to higher dose in ReN001 stem cell trial for stroke
Guildford, UK, 1 September 2011: ReNeuron Group plc (LSE: RENE.L) ("ReNeuron" or "the Company") today provides an update on progress with the PISCES Phase I clinical trial of its ReN001 stem cell therapy for disabled stroke patients.
The Company is pleased to report that the independent Data Safety Monitoring Board (DSMB) for the clinical trial has recommended that the trial advances to the evaluation of a higher dose of ReN001. In arriving at this recommendation, the DSMB reviewed safety data from the first dose cohort of three patients treated with ReN001. The first patient treated in the cohort was assessed at nine months post-treatment, the second patient at six months and the third patient at three 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.
As previously reported, the Company expects that the next dose cohort of three 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 the UK and beyond.
The PISCES study (Pilot Investigation of Stem Cells in Stroke) is the world's first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world. The trial is being conducted in Scotland at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. In this Phase I 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 ischaemic stroke, the most common form of the condition. 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. The Principal Investigator for the trial is Professor Keith Muir, SINAPSE Professor of Clinical Imaging, Centre for Stroke Research, Institute of Neuroscience & Psychology at the University of Glasgow. Patients in the clinical trial will be monitored for two years, with longer term follow-up procedures in place thereafter.
Professor Muir will present further data regarding progress with the PISCES trial at the Stroke Association's 6th UK Stroke Forum Conference in Glasgow from 29 November to 1 December 2011. |
