ReNeuron

We are a leading, clinical-stage stem cell business. Our primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.

We have used our 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 drug treatments. Our lead therapeutic candidate is our ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke. This treatment is currently in clinical development. We are also developing stem cell therapies for other conditions such as peripheral arterial disease, a serious and common side effect of diabetes, and blindness-causing diseases of the retina.

We have also developed a range of stem cell lines for non-therapeutic applications – our ReNcell® products for use in academic and commercial research.  Our ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by USA-based Merck Millipore.

Our shares are traded on the London AIM market under the symbol RENE.L.

We have used our cell expansion and screening technologies to develop “off-the-shelf” stem cell therapies for serious conditions such as stroke where the patient populations are significant and where few if any alternative treatments exist.  Unlike conventional drug treatments which typically address the symptoms of disease, the potential of stem cell treatments such as ours is to address the underlying causes of the target disease.  Our stem cell treatments have been shown in pre-clinical testing to stimulate natural repair mechanisms in the organs affected by the disease in question, leading to a reduction in the functional impairments associated with the disease.

Our lead therapeutic candidate is our ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke.  This treatment is currently in clinical development.  We are also developing stem cell therapies for other conditions such as peripheral arterial disease, a serious and common side effect of diabetes, and blindness-causing diseases of the retina.

Our stem cell therapies for stroke and peripheral arterial disease utilise our lead CTX neural stem cell line.  The characteristics of this cell line give ReNeuron some distinct technical and competitive advantages in the field. The CTX cell line has been taken through a full manufacturing scale-up and quality-testing process. As such, it represents a standardised, clinical and commercial-grade cell therapy product capable of treating all eligible patients presenting with the diseases targeted, without the need for additional immunosuppressive drug treatments.  The CTX cells that are being used in the ongoing PISCES Phase I clinical trial with ReN001 in disabled stroke patients have been 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 cell lines for subsequent ReN001 clinical trials of for the market – all such cells can simply be expanded from the existing banked and tested product.

We have also developed a range of stem cell lines for non-therapeutic applications - our ReNcell® products for use in academic and commercial research.  Our ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by USA-based Merck Millipore.

ReN001 for Stroke

A stroke occurs when blood flow leading to, or in, the brain is blocked (ischaemic stroke) or a blood vessel in the brain ruptures (haemorrhagic stroke), which can result in damage to the nerve cells in the brain and a loss of bodily functions. Stroke is the single largest cause of adult disability in the developed world Over 150,000 people suffer a stroke each year in the UK, and over 700,000 people in the US. Approximately 80% of these strokes are ischaemic in nature. Our ReN001 stem cell therapy seeks initially to treat those patients who have suffered an ischaemic stroke and have been left disabled by it. These patients constitute approximately one half of stroke survivors.

The annual health and social costs of caring for disabled stroke patients is estimated to be in excess of £5 billion in the UK, with stroke patients occupying 25 per cent of long term hospital beds. In the US, the annual direct and indirect costs of stroke are estimated to be in excess of US$50 billion. The type of stroke treatment a patient should receive depends on the stage of disease. Generally there are three treatment stages of stroke:

Prevention - treatments to prevent a first or recurrent stroke are based on treating associated risk factors, e.g. high cholesterol, smoking and diabetes;

Treatment immediately after the stroke; acute-phase stroke treatments attempt to arrest a stroke whilst it is happening by dissolving the blood clot that has caused the infarct; and

Post stroke rehabilitation - the aim of post stroke rehabilitation is to improve both functional and cognitive recovery in the patient some weeks or months after the stroke event.

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Other therapeutic programmes

Beyond ReN001 for stroke, our other cell therapy programmes are at the research or pre-clinical stages of development. Our ReN009 stem cell therapy is being developed as a treatment for peripheral arterial disease, a serious and common side-effect of diabetes. Our ReN003 programme for blindness-causing diseases of the retina is partnered with the Schepens Eye Research Institute (an affiliate of Harvard Medical School in Boston, USA). This programme is initially focused on retinitis pigmentosa, a disease leading to progressive loss of vision due to loss of the photoreceptor cells found in the retina.  

We are also exploring the clinical potential of our lead CTX stem cell line in other categories of the stroke patient population and in other neurological conditions where the mechanisms of action of the cells may be relevant.  This is with a view to commencing further clinical trials in these indications as quickly as possible, based on the very significant pre-clinical safety and efficacy data package already in existence with the CTX cells, as well as the emerging early clinical data from the PISCES stroke clinical trial, in which the CTX cells are being used clinically.

Ultimately, we expect to realise value by out-licensing our stem cell therapies to commercial development partners at the appropriate points in their respective development programmes. 

ReNcell® products

Stem cells have significant potential beyond their use in cell therapy treatments for disease. For example, they are being increasingly used in the drug discovery process as a screening tool against which drug candidates can be screened for toxicity. We have developed a range of cell lines for non-therapeutic applications in academic or commercial research, our ReNcell® products. 

ReNcell®VM is a neural cell line derived from the ventral mesencephalon region of the brain, and ReNcell®CX is derived from the cerebral cortex. A series of specifications have been developed describing the ability of these cell lines to grow and retain stability after culturing, to differentiate readily into the principal neural cell types, including neurons, and for the derived neurons to show physiological properties indicative of mature neurons. 

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Clinincal Trials 

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 PISCES clinical 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 safety study, ReNeuron’s 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 Principal Investigator for the trial is Professor Keith Muir, SINAPSE Professor of Clinical Imaging, Division of Clinical Neurosciences at the University of Glasgow. The aim of the clinical trial is to evaluate the safety of the implantation technique and to establish the side effect profile associated with the implantation of ReN001 stem cells in patients who have suffered an ischaemic stroke.

Patients in the PISCES trial will be followed up over a two year period. Ongoing monitoring of the patients will also continue in the longer term following the two year end-point. Although the primary endpoints of the clinical trial relate to the safety and tolerability of the ReN001 treatment, a number of clinical assessments of the patients in the trial will be made to evaluate changes in both motor and cognitive function over time.  We hope to use these potential efficacy measures in the design of subsequent clinical studies where efficacy of the treatment would be the primary endpoint.

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Bryan Morton BSc MBA - Non-executive Chairman

Bryan Morton was appointed to the Board in October 2008 and appointed as Chairman in August 2011. He is Chief Executive Officer of EUSA Pharma, Inc., a rapidly growing specialty pharmaceutical company he founded in 2006. He is a non-executive director of Dechra Pharmaceuticals plc, Aircraft Medical Ltd, and is a member of the Pilgrim Software global advisory board. He began his pharmaceutical career in sales and has held positions in medical information, marketing, sales management, business development and general management during a 30 year career in the healthcare industry, largely with Merck and Co. Inc. and Bristol Myers Squibb. In 2003, he founded Zeneus Pharma, which was sold to Cephalon Inc. in late 2005 for US$360 million. He has a BSc in Pharmacology from Aberdeen University and a MBA from Durham University.

Michael Hunt BSc ACA, Chief Executive Officer

Michael Hunt joined ReNeuron as Chief Financial Officer and was appointed Chief Operating Officer in September 2003 and Chief Executive Officer in July 2005. Prior to ReNeuron, he spent six years at Biocompatibles International plc (sold to BTG plc) where he held a number of senior financial and general management positions. His early industrial career was spent at Bunzl plc. He sits on the BioIndustry Association’s Cell Therapy and Regenerative Medicine Advisory Committee and its Finance and Tax Advisory Committee. He is a Senior Industry Group member of the UK Government’s Office for Life Sciences and a member of the UK Technology Strategy Board’s RegenMed Advisory Group. He read economics at University College London and qualified as a chartered accountant with Ernst & Young in London.

Dr John Sinden BA MA Ph.D - Chief Scientific Officer

Dr John Sinden is a scientific co-founder of ReNeuron. Prior to joining ReNeuron as Chief Scientific Officer in October 1998, he was Reader in Neurobiology of Behaviour at the Institute of Psychiatry at Kings College London. He graduated in Psychology from the University of Sydney and completed a Ph.D. in Neuroscience from the University of Paris at the College de France. He subsequently held post-doctoral appointments at Oxford University and the Institute of Psychiatry prior to joining the permanent staff of the Institute in 1987. Dr. Sinden is a member of the Royal Society of Medicine, the Society for Neuroscience and the International Society for Cellular Therapies. He sits on the Industry Committee of the International Society for Stem Cell Research, the Scientific Advisory Board of the Minda de Gunzburg Center for Ocular Regeneration, Schepens Eye Research Institute at Harvard Medical School, and the Expert Working Group on Cell and Gene Therapies for the Bioindustry Organization BioSafe Committee.

John Berriman BEng MBA - Non-executive Director

John Berriman was appointed to the Board in July 2011. He is the Chairman of Heptares Therapeutics Ltd, Pronota NV and past Chairman (now deputy Chairman) of Algeta ASA (listed on the Oslo stock exchange). He is also a non-executive director of MicroMet, Inc. (listed on NASDAQ). Previously he was a director of Abingworth Management, an international healthcare venture capital firm, where he was involved in founding, financing and serving as a director of several biotechnology companies in Europe and the USA – many of which obtained listings on public stock exchanges.  Prior to that, he spent 14 years with Celltech Group plc and was a member of its Board when it listed on the London Stock Exchange in 1994. He has a degree in Chemical Engineering from the University of Cambridge and an MBA from the London Business School. In addition to the positions mentioned above, he has in the last five years been a non-executive director of Ablynx NV and Oxxon Therapeutics Holdings, Inc.

Simon Cartmell BSc MSc - Non-executive Director

Simon Cartmell was appointed to the Board in July 2011. He was, until June 2010, Chief Executive Officer of ApaTech Ltd, which he built into a world leader in orthobiologics. Its sale to Baxter International Inc for $330m was completed in March 2010. Prior to ApaTech he was CEO of Celltech Pharmceuticals and a director of Celltech Group plc. Before that, he was Chief Operating Officer of Vanguard Medica plc. His early career was spent at Glaxo plc in multiple senior UK and global commercial strategy, product development, supply chain, marketing, sales and business development roles. He is a Medical Microbiology graduate from Manchester University and an alumnus of the London Business School Sloan Fellowship Programme. He is currently Executive Chairman of OSspray Ltd, an emerging dental company, and he is also a non-executive director of Phase4 Ventures, an adviser to the MTI/University of Manchester Premier Fund and to several emerging life science and medical technology companies in the UK and internationally.

Mark Docherty BEng ACA, Non-executive Director

Mark Docherty was appointed to the Board in March 2003. He is a chartered accountant and holds a BEng in Mechanical Engineering from Sheffield University. He was a founding director of Merlin Biosciences Limited (now Excalibur Fund Managers Limited) and was actively involved in the structuring and financing of many of the Merlin portfolio companies. Previously, he was a Manager in the Corporate Finance Group of Arthur Andersen. He is also a non-executive director of CBT Development Limited and Pantherix Limited.

Dr Paul Harper BSc Ph.D. - Non-executive Director

Dr Paul Harper was appointed to the Board in August 2005. He is a graduate of Leeds University (Microbiology/Virology). He initially pursued a career in drug discovery and development with Glaxo Group Research as Head of Antimicrobial Chemotherapy, Johnson & Johnson Limited as Director of Research & Development and with Unipath plc. This was followed by work in a number of start-up companies and SMEs as Chief Executive Officer or adviser. These included, as CEO, preparing Cambridge Antibody Technology PLC for flotation on the London Stock Exchange and founding Provensis Limited to develop a drug device product. Currently Chairman of Angel Biotechnology plc, Physiomics plc, Sareum Holdings plc and three other private biotechnology/devices businesses.

Professor Trevor Jones CBE Ph.D. DSc FKC FPS FRSC Hon FRCP FBPharmcolS - Non-executive Director

Professor Trevor Jones was Chairman of the ReNeuron Group from February 1999 to August 2011. He was formerly Director General of the Association of the British Pharmaceutical Industry (ABPI), and was, until 1994, Research & Development Director at Wellcome plc. He has been awarded honorary doctorates and Gold Medals from six universities; he has fellowships from Kings College London, the Royal Society of Chemistry, the Royal Pharmaceutical Society of Great Britain, the British Pharmacological Society, the Royal College of Physicians and its Faculty of Pharmaceutical Medicine. He is a founder member of the Geneva-based public/private partnership, the Medicines for Malaria Venture and in 2004 he was appointed to the World Health Organisation Commission on Innovation and Public Health Organisation on Intellectual Property Rights Health. He was for 12 years a member of The UK Government regulatory agency, The Medicines Commission. He sits on the Boards of a number of life science companies including Allergan, Inc. and Sigma-Tau S.p.A.