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ReNeuron Receives Final Regulatory Approval to Commence Landmark Stroke Clinical Trial in UK

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ReNeuron Group plc announces that the UK Gene Therapy Advisory Committee (GTAC) has given a full and final Favourable Opinion to ReNeuron’s proposed first-in-man clinical trial with its ReN001stem cell therapy for stroke. GTAC acts as the national research ethics committee for gene therapy and stem cell therapy clinical trials in the UK.

This approval represents the final national regulatory step in taking the ReN001 therapy into patients in the UK, following regulatory approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) last year.

The Company is now working with its chosen contract research organization (CRO) to finalize local arrangements for the clinical trial at the trial site as well as completing various other contractual, registration and documentation requirements, after which patient recruitment and evaluation for the trial will begin, most likely in April of this year. Further information regarding patient recruitment for the clinical trial will be made available by the centre concerned in due course.

In this Phase I trial, the world’s first using expanded neural stem cells in this indication, ReNeuron’s ReN001 stem cell therapy will be administered to stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.

The ReN001 clinical trial will take place through the NHS at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. 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 SGH, Professor Muir leads one of Europe’s most innovative and well-recognized stroke treatment centres.

The 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. 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 initially on more severely disabled stroke patients.