• First ever clinical trial in stroke using expanded neural stem cells
• First company to gain approval to undertake stem cell trial in the UK
• Promotes clinical innovation in the NHS
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.
Dr. Keith Muir said:
“We are pleased that the first patient in the PISCES trial has undergone surgery successfully. Stroke is a common and serious condition that leaves a large number of people with significant disability. In this trial, we are seeking to establish the safety and feasibility of stem cell implantation, which will require careful follow-up of the patients who take part. We hope that in future it will lead on to larger studies to determine the effects of stem cells on the disabilities that result from stroke.”
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“The initiation of the PISCES clinical trial is a major and hard-won milestone for ReNeuron and a significant milestone in the development of therapies to address the severely disabling effects of ischaemic stroke. We are delighted to be working with Professor Keith Muir and his team at one of Europe’s pre-eminent stroke treatment centres and, in so doing, helping to promote the uptake of clinical innovation in the NHS system. Our thanks and best wishes go to the first patient and his family for their participation in this important and ground-breaking clinical trial.”
Michael Hunt, Chief Executive Officer – ReNeuron
Dr John Sinden, Chief Scientific Officer – ReNeuron +44 (0) 1483 302560
Mark Court, Isabel Podda
Buchanan Communications + 44 (0) 20 7466 5000
Emma Earl, Oliver Rigby
Daniel Stewart & Company plc +44 (0) 20 7776 6550
Alastair Stratton, Tim Graham
Matrix Corporate Capital LLP +44 (0) 20 3206 7000
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 haemorrhagic 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 per cent 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.
Source: UK Stroke Association
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 standardised, 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 PISCES Phase I trial, a total of 12 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 Centre, 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 f or 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.
ReNeuron is a leading, clinical-stage stem cell business. Its primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.
ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered “off-the-shelf” to any eligible patient without the need for additional immunosuppressive drug treatments. ReNeuron’s lead candidate is its ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke. This therapy is currently in early clinical development. ReNeuron’s ReN009 stem cell therapy is being developed as a treatment for peripheral arterial disease, a serious and common side-effect of diabetes. The Company is also developing stem cell therapies for other conditions such as blindness-causing 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.
This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as “should”, “expects”, “estimates”, “believes” or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron’s current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron’s actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements.