ReNeuron, the UK-based stem cell research and development company, is today presenting ground-breaking efficacy data with its lead stem cell line at the American Neurological Association Annual Meeting (ANA) in Toronto, Canada.
The Company has generated important and unique pre-clinical efficacy data in stroke using ReN001, a stable human neural (brain) stem cell line pre-selected from ReNeuron’s library of stem cell lines. This particular cell line, derived from the cortex region of the brain, was selected for testing in a validated rat model of stroke. Injection of the cells into the damaged brain significantly improved sensory motor abilities impaired by the stroke.
The ReN001 stem cell line was generated using ReNeuron’s proprietary c-mycERTAM technology. This is a fully controllable system for generating stem cell lines that are non-tumour-forming and have stable, normal genomes, both pre-requisites for future clinical development. ReN001 was pre-selected based on a set of required desirable characteristics, including the ability of the stem cells to differentiate into large numbers of mature neurons, as well as their ability to survive in vivo and migrate to the area of brain damage.
These breakthrough results clearly demonstrate the ability of ReN001 to treat serious brain damage in a validated stroke model. The wider significance is that this cell line has been developed in manner that will permit its scale-up and eventual clinical use, subject to approval by regulatory agencies.
ReNeuron is now progressing its ReN001 stem cell therapy for stroke into manufacturing scale-up and late pre-clinical development. The Company hopes to have approval to commence clinical trials by the end of 2005, initially in patients who have suffered long-term disabilities after stroke. ReNeuron believes ReN001 could be the first such clinical-stage neural stem cell programme addressing a major disease condition.
ReNeuron has today given a separate update on its other development programmes and funding plans. The Company will be making further presentations on progress with its cell therapy programmes at other key conferences in the US during October. Details of these conferences can be found on ReNeuron’s website at www.reneuron.com.
Commenting on the efficacy data, Professor Trevor Jones CBE, Chairman of ReNeuron said:
“These results represent a major breakthrough for ReNeuron and a significant milestone in the wider cell therapy field. We believe that they give ReNeuron a critical competitive and technological edge in the race to realise the huge therapeutic potential of stem cells.
“ReNeuron has committed much time and resource to successfully developing what it believes to be the gold standard for a viable stem cell therapy: a stable, efficacious and scalable system with the potential to serve a large unmet patient need. It is heartening to see a UK company taking a lead in this incredibly exciting area of medical science, and benefiting from the supportive environment that currently exists in the UK for stem cell research.”
Michael Hunt, Chief Operating Officer and Finance Director, ReNeuron
Dr John Sinden, Chief Scientific Officer, ReNeuron
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David Yates/Lucy Briggs, Financial Dynamics
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ReNeuron believes its approach to stem cell therapy confers significant advantages over competitor technologies, in terms of the Company’s ability to generate stable, functional cell lines with the characteristics necessary for scale-up to a viable cell therapy product capable of treating large patient populations.
ReNeuron has demonstrated convincing efficacy data in a pre-clinical model of stroke, and its ReN001 stem cell therapy for stroke is now being scaled up ahead of late pre-clinical development. The Company aims to have approval to commence clinical trials with ReN001 by the end of 2005.
ReNeuron has broadened its product pipeline by initiating programmes to develop stem cell therapies for Type 1 diabetes, Parkinson’s disease, Huntington’s disease and diseases of the retina. ReNeuron has also leveraged its stem cell technologies into non-therapeutic areas such as drug discovery – its ReNcellTM product.
More information on ReNeuron and its programmes can be found on the Company’s website at www.reneuron.com.
There are an estimated 50 million stroke survivors worldwide, with around two million patients diagnosed annually. Approximately 30 per cent of stroke patients require ongoing nursing care, estimated to cost as much as $45 billion per annum in the US alone. (Sources: BCC, Scrip, US National Stroke Association).