Guildford, UK, 21 November 2007: ReNeuron Group plc (LSE:RENE.L) today welcomes the publication of ground-breaking research into the reprogramming of adult human stem cells undertaken by teams lead by Shinya Yamanaka and James Thomson of, respectively, Kyoto University and the University of Wisconsin-Madison.
By the insertion of a combination of genes into somatic skin cells, the teams have been able to reprogram the cells back to an embryonic-like state, thus potentially avoiding the use of embryos to derive pluripotent stem cells.
One of the four genes used in the research was c-myc, a gene over-expressed in embryonic development. ReNeuron also uses a variant of this gene to derive its own stem cell lines for therapeutic development, and has a world-wide exclusive license to the use of this gene in the development of neural stem cell therapies. Crucially, ReNeuron has developed a fully controllable version of the gene, c-mycER, by which cell growth can be completely arrested, via a chemically-based safety switch, prior to introduction of the stem cells into the patient.
ReNeuron has utilised this c-mycER platform cell expansion technology to convert exciting science into commercially viable therapeutic stem cell lines. As part of the late pre-clinical development of its lead ReN001 cell therapy for stroke, ReNeuron has also demonstrated the safety of its technology as applied to ReN001, in long-term pre-clinical safety studies. ReNeuron intends to shortly submit an amended Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to commence initial clinical trials with ReN001 in the US.
John Sinden, Chief Scientific Officer of ReNeuron, said: “We believe that this research breakthrough has much relevance to ReNeuron’s approach to the expansion of stable and biologically potent stem cell lines. We regard the research as a strong scientific endorsement of the technique of gene-based manipulation of stem cells such as that employed by ReNeuron in the development of its own, commercially viable, stem cell therapeutics, including our lead product, ReN001 for stroke.”
Notes to editors
ReNeuron is a leading, UK-based stem cell therapy business. It is applying its novel stem cell platform technologies in the development of ground-breaking stem cell therapies to serve significant and unmet or poorly-met clinical needs. The Company operates from laboratories in Surrey, UK and Los Angeles,California, USA.
ReNeuron has used its c-mycER technology to generate genetically stable neural stem cell lines. This technology platform has multi-national patent protection and is fully regulated by means of a chemically-induced safety switch. Cell growth can therefore be completely arrested prior to in vivo implantation.
ReNeuron has filed for approval to commence initial clinical studies in the US with its lead ReN001 stem cell therapy for chronic stroke disability. This represents the world’s first such filing concerning a neural stem cell treatment for a major neurological disorder. There are an estimated 50 million stroke survivors worldwide, approximately one half of which are left with permanent disabilities. The annual health and social costs of caring for these patients is estimated to be in excess of £5 billion in the UK and in excess of US$50 billion in the US.
In addition to its stroke programme, ReNeuron is developing stem cell therapies for Parkinson’s disease, Huntington’s disease, Type 1 diabetes and diseases of the retina. The Company recently announced the acquisition of the business assets of AmCyte Inc. in the US, bringing clinically-tested cell encapsulation technology to ReNeuron’s ReN002 diabetes programme.
ReNeuron has leveraged its stem cell technologies into non-therapeutic areas � its ReNcell® range of cell lines for use in research and in drug discovery applications in the pharmaceutical industry. ReNeuron’s ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by 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.
Data sources: UK Stroke Association; American Stroke Association.
Michael Hunt, Chief Executive Officer
Dr John Sinden, Chief Scientific Officer
Tel: +44 (0) 1483 30256
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