Guildford, UK, 8 March 2006: ReNeuron Group plc (LSE: RENE.L) today announces that it has successfully completed the scale-up and cell banking of its lead ReN001 stem cell product for stroke. Master and Working cell banks have been manufactured to full Good Manufacturing Practice (GMP) standard, having been fully tested for purity, sterility and stability. The banking and testing process took place at a contract manufacturer in the UK.
Importantly, these cell banks contain the vials of ReN001 cells from which all future clinical and in-market product will eventually be grown. This gives the Company the potential to progress its ReN001 stroke therapy to the clinic and beyond without the need to re-derive ReN001 cells from source material at any stage in the future, thereby reducing risk, cost and time from the development pathway for this product.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“Completion of cell banking represents a further key milestone for our ReN001 stem cell therapy for stroke. We have now shown that our proprietary
c-mycERTAM technology has the ability to scale up human stem cells into a well-characterised, consistent and stable product for wide-scale clinical use. We believe that this, together with our recently announced repeat pre-clinical efficacy data in stroke, places ReNeuron in a unique competitive position with respect to its ReN001 programme.”
Notes to editors
About ReNeuron Group plc
ReNeuron is a leading, UK-based adult stem cell therapy business. The Company 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.
ReNeuron has used its c-mycERTAM 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.
The Company’s lead stem cell therapy, ReN001 for chronic stroke disability, is in late pre-clinical development. Subject to successful completion of pre-clinical testing, the Company plans to file for approval to commence initial clinical trials in stroke later this year, with trials commencing as soon as possible thereafter.
The Company has also generated pre-clinical efficacy data with its ReN005 stem cell therapy for Huntington’s disease, a rare, genetic and fatal neurodegenerative disorder which affects around 1 in 100,000 people. This programme is in pre-clinical development.
In addition to its stroke and Huntington’s disease programmes, ReNeuron is developing stem cell therapies for Parkinson’s disease, Type 1 diabetes and diseases of the retina.
ReNeuron has also leveraged its stem cell technologies into non-therapeutic areas – its ReNcellTM range of cell lines for use in drug discovery applications in the pharmaceutical industry.
ReNeuron’s shares are traded on the London AIM market under the symbol RENE.L, and its warrants are traded under the symbol RENW.L.
Further information on ReNeuron and its products can be found at www.reneuron.com.
Michael Hunt, Chief Executive Officer
John Sinden, Chief Scientific Officer
Tel: 44 (0)1483 302 560
Tel: 44 (0)20 7831 3113
The terms “ReNeuron” or “the Company” refer to ReNeuron Group plc and its subsidiary undertakings.