Guildford, UK, 18 November 2005: ReNeuron Group plc (LSE: RENE.L) today announced that it has generated provisional pre-clinical data indicating that its lead ReN001 cell line for stroke does not form tumours following implantation. The ability to demonstrate a lack of tumorigenicity in vivo is one of the principal safety hurdles that must be overcome before regulatory authorities will allow commencement of human clinical trials using stem cell-based therapies.
ReNeuron’s data were generated in two validated rodent models, part of the package of studies making up the Company’s overall pre-clinical development programme for its ReN001 stroke therapy ahead of initial human clinical trials. A key safety feature of the Company’s platform c-mycERTAM technology, from which its ReN001 therapy was derived, is its ability to fully control and arrest cell proliferation prior to implantation of those cells into the brain.
One study has reported in full, with nothing abnormal reported. In particular, there was no evidence of tumour formation. A second study in a more sensitive model is also well advanced and, to date, nothing abnormal has been seen or reported in this second study.
Commenting on the announcement, John Sinden, CSO of ReNeuron, said:
“We are greatly encouraged by these provisional safety data read-outs. They represent an important step forward in terms of demonstrating the ability of our c-mycERTAM platform technology to deliver a safe and efficacious stem cell therapy for a large-scale indication, in this case our ReN001 therapy for stroke. The findings are indicative of the power of c-mycERTAM to fully control the proliferative capacity of stem cells, a vital safety characteristic of the technology from a regulatory perspective.”
Notes to editors
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 way 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. The Company plans to file for approval to commence initial clinical trials in stroke by mid-2006, with trials commencing as soon as possible thereafter.
In addition to its ReN001 stroke programme, ReNeuron has programmes to develop stem cell therapies to address Huntington’s disease, 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.
The Company successfully completed its flotation on the London AIM market in August 2005, raising £9.5million before expenses. At flotation, the Company also issued warrants which, if exercised, will raise a further £5.7m for the Company by February 2007. ReNeuron’s shares are traded 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
Financial Dynamics – Europe
David Yates, Sarah MacLeod
Tel: +44 (0) 20 7831 3113
Financial Dynamics – US
Jonathan Birt, John Capodanno
Tel: +1 (212) 850 5755
The terms “ReNeuron” or “the Company” refer to ReNeuron Group plc and its subsidiary undertakings.