Guildford, UK, 16 November 2010: ReNeuron Group plc (LSE: RENE.L) today announces that the first patient has been treated with the Company's ReN001 stem cell therapy for stroke in a ground-breaking UK clinical trial. 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. ReNeuron is the first company to have received regulatory approval for any stem cell-based clinical trial in the UK. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.
The first patient in the PISCES trial was treated at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board and was safely discharged two days after the straightforward neuro-surgical procedure used to administer the ReN001 cells.
In this Phase I trial, ReNeuron's ReN001 stem cell therapy is being administered to stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. The Principal Investigator for the trial is Professor Keith Muir, SINAPSE Professor of Clinical Imaging, Division of Clinical Neurosciences at the University of Glasgow. At Glasgow Southern General, Professor Muir leads one of Europe's most innovative and well-recognised stroke treatment centres.
The PISCES trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial. Patients in the trial will be monitored for two years, with longer term follow-up procedures in place thereafter.
Assuming a satisfactory independent Data Safety Monitoring Board review of the first patient's progress in December, the remainder of the first dose cohort in the trial will be treated shortly thereafter. Subject to satisfactory safety data arising from the early patient cohorts in the trial, the Company intends to pursue an accelerated clinical development pathway with ReN001, focusing on particular stroke patient groups who are expected to most benefit from the therapy. |
