Guildford, UK, 24 January 2006: ReNeuron Group plc (LSE: RENE.L) today announces that it has generated further positive pre-clinical efficacy data with its ReN001 stem cell therapy for stroke. These follow-on studies were undertaken in validated rodent models of stroke equivalent to those used in the original efficacy studies undertaken by the
Company. The delivery method and implant location of the ReN001 cells in the brain were selected to mimic as far as possible the protocols that are likely to be followed in human clinical trials. Additionally, the ReN001 cells used in these follow-on studies were drawn from production lots manufactured to cGMP1 standard, equivalent to those that will be used in clinical trials. The follow-on studies were designed to test the effects of different cell doses on efficacy.
The results successfully replicated the positive effects of ReN001 at an equivalent dose to that used in the original efficacy studies. Furthermore, and importantly, the new studies showed a clear dose-ranging effect, indicating that a higher dose has the potential to reverse both the sensory and motor symptoms associated with stroke disability.
These new results will be presented at the US Center for Business Intelligence’s 2nd Conference on Commercializing Stem Cells for Therapeutic Applications in Cambridge, MA, USA on 9-10 March. They will also form part of the Company’s IND2 data package to support its impending application to the FDA3 to commence initial clinical trials in the US with ReN001.
A paper describing the Company’s original pre-clinical efficacy data with ReN001 has been accepted for publication in the Journal of Experimental Neurology and will appear on-line shortly. The paper will also form part of a special edition of the Journal on stem cells and ischaemic brain disease that is due to appear in print in May 2006. In the paper, ReNeuron scientists demonstrate the unique biological characteristics of ReN001 cells and their ability to reverse chronic sensori-motor deficits in validated rodent models of stroke after injection into the brain.
A separate paper written by the Chairman of ReNeuron’s Clinical Advisory Board, Professor Sid Gilman, is due to appear in the same special issue of the Journal, and has already been published on-line. Professor Gilman is the William J Herdman Professor of Neurology at the University of Michigan. In his paper, Professor Gilman describes time course factors and current treatment options available or in development for stroke patients as they move from the acute to sub-acute and chronic phases of their condition. The current lack of treatment options for patients left with permanent disabilities is highlighted, the sub-group ReNeuron is targeting with its ReN001 stem cell therapy and which accounts for approximately one half of all stroke survivors.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“The results of these follow-on studies are highly significant and will form an important part of our IND data package for ReN001. They further demonstrate the capability of our c-mycERTAM platform technology to produce stem cell lines that are stable, capable of rapid and efficient scale-up, and repeatedly efficacious in validated pre-clinical models of major disease conditions.”
1. Current Good Manufacturing Practice
2. Investigational New Drug
3. US Food and Drug Administration
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 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. 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.
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
Tel: 44 (0)20 7831 3113
The terms “ReNeuron” or “the Company” refer to ReNeuron Group plc and its subsidiary undertakings.