Guildford, UK, 25 April 2007: ReNeuron Group plc (LSE: RENE.L) welcomes today’s vote by the European Parliament to create a regulatory framework and single European marketing authorisation for gene therapy, cell therapy and tissue engineered products. MEPs voted in favour of a compromise package of amendments and Parliament rejected all ethical amendments banning products derived from human embryonic stem cells from the scope of the Regulation. These amendments significantly increase the possibility of early adoption of the Regulation. The Regulation will harmonise patient access to innovative treatments in Europe by removing the hurdles created by the many differing regulatory systems across the Continent.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“Today’s vote is very significant for ReNeuron and all those involved in developing advanced and innovative therapies for patients in Europe and elsewhere. A significant obstacle in ensuring access to these treatments across Europe has been removed, making possible the establishment of a workable regulatory system which will assess the efficacy and safety of these therapies in a consistent manner. This can serve only to benefit the patients in need of these treatments as well as those working hard to provide them.”
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.
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. ReNeuron has also generated pre-clinical efficacy data with its ReN005 stem cell therapy for Huntington’s disease, a genetic and fatal neurodegenerative disorder that affects around 1 in 10,000 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 research and in drug discovery applications in the pharmaceutical industry. ReNeuron’s ReNcellTM CX and ReNcellTM 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 302560
Tel: +44 (0) 20 7831 3113
The terms �ReNeuron’, �the Company’ or �the Group’ used in this statement refer to ReNeuron Group plc and/or its subsidiary undertakings, depending on the context.