Stroke Clinical Trial in UK

Introduction

Main Digest

ReNeuron Group plc today announces that the UK Gene Therapy Advisory Committee (GTAC) has given a full and final favorable Opinion to ReNeuron's proposed first-in-man clinical trial with its ReN001 stem 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 center concerned in due course.

In this ground-breaking 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 centers.

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.

Michael Hunt, Chief Executive Officer of ReNeuron, said:

"This final approval represents the culmination of many months of work in taking our ReN001 therapy through the regulatory pathway in the UK, a process untested by other stem cell therapy approaches of this type. We are therefore pleased to have in many ways pioneered this pathway for subsequent cell therapy applications, including, of course, those of ReNeuron's other cell therapy candidates currently in development. We are also very pleased to be undertaking this ground-breaking clinical trial at a leading NHS hospital and we look forward to reporting on progress with the trial as it finally gets underway this year. "

About stroke

Approximately 150,000 people suffer a stroke in the UK each year. The vast majority of these strokes are ischaemic in nature, caused by a blockage of blood flow in the brain (as opposed to a hemorrhagic or bleeding stroke).

Approximately one half of all stroke survivors are left with permanent disabilities as a result of the damage caused to brain tissue arising from the stroke. The annual health and social costs of caring for these patients is estimated to be in excess of £5 billion in the UK, with stroke patients estimated to be occupying at least 25 percent of long term hospital beds.

The only current treatment for ischaemic stroke patients occurs in the acute phase of the condition (within several hours of the stroke), when anti-clotting agents are administered to dissolve the clot causing the blockage in blood flow to the brain. Only a small proportion of patients get to the hospital in time to be treated in this way.

Beyond the acute phase, there are no existing treatments, other than preventative or rehabilitation measures, to alleviate the disabilities suffered by stroke patients who have survived their stroke.

About ReNeuron's ReN001 stem cell therapy for stroke

ReNeuron's ReN001 cell therapy for stroke consists of a neural stem cell line, designated CTX, which has been generated using the Company's proprietary cell expansion and cell selection technologies and then taken through a full manufacturing scale-up and quality-testing process. As such, ReN001 is a standardized, clinical and commercial-grade cell therapy product capable of treating all eligible patients presenting.

ReN001 has been shown to reverse the functional deficits associated with stroke disability when administered several weeks after the stroke event in relevant pre-clinical models of the condition. Extensive pre-clinical testing also indicates that the therapy is safe, with the ReN001 cells eventually cleared from the body with no adverse safety effects arising.

In the first-in-man, Phase I trial, a total of twelve patients will receive the ReN001 therapy between 6 and 24 months after their stroke. If ultimately shown to be safe and effective clinically, ReN001 would therefore offer a significant new treatment option for stroke survivors. The therapy offers the potential for a degree of recovery of function in disabled stroke patients, resulting in greater independence and quality of life for these patients and reduced reliance on health and social care systems.

The ReN001 cells that are being used in the initial clinical trial are taken from the existing manufactured cell banks that will form the basis of the eventual marketed product. There will therefore be no need to re-derive and test new ReN001 cell lines for subsequent clinical trials or for the market - all such cells can simply be expanded from the existing banked and tested product.

About the Institute of Neurological Sciences at Glasgow University

The clinical Stroke Research Group of the Division of Clinical Neurosciences is based at the Institute of Neurological Sciences at Glasgow University, and has major collaborations, internally with the Glasgow Experimental MRI Center, with SINAPSE (Scottish Imaging Network: A Platform for Scientific Excellence), and with the Translational Medicine Research Initiative (TMRI). Around 900 patients per year are admitted through the Acute Stroke Unit, which provides stroke services to the population of south Glasgow and specialist stroke treatments for the West of Scotland.

The unit is the highest user of acute clot-busting (thrombolytic) treatment in the UK at present, and has been extensively involved in clinical trials in stroke. Major research interests include evaluation of advanced brain imaging techniques in acute stroke, development of novel brain imaging techniques, improving the use of clot-busting drug treatments in stroke, and developing trial methodology for evaluation of regenerative treatments. The group has support from the Stroke Association, the Medical Research Council, and the TMRI. Further work with regenerative strategies include collaborations with groups developing both drug-based and stem cell therapies across Europe.

About ReNeuron

ReNeuron is a leading, UK-based stem cell business. Its primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need.

ReNeuron has regulatory approval for a Phase I clinical trial in the UK with its lead ReN001 stem cell therapy for disabled stroke patients. Patient recruitment for this trial will commence shortly. The Company is also developing stem cell therapies for a number of other conditions, including peripheral arterial disease and diseases of the retina.

ReNeuron has also developed a range of stem cell lines for non-therapeutic applications - its ReNcell® products for use in academic and commercial research. The Company's ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by USA-based Millipore Corporation.

ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com

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