- Application filed in November 2006 to commence initial clinical trial in the US with lead ReN001 stem cell therapy for stroke
- Further FDA guidance recently received, clarifying additional data requirements in support of application
- Submission of further data in support of application on track for Q4 2007
- Prestigious grant awarded by the Michael J Fox Foundation for ReN004 Parkinson’s disease programme
- Research collaboration initiated with Schepens Eye Research Institute (Harvard Medical School) for ReN003 retinal disease programme
- Insulin-producing islet cells generated in ReN002 diabetes programme
- Worldwide market launch of ReNcell® neural stem cell lines for non-therapeutic applications and collaboration signed to develop ReNcell® liver cell products
- Key European patent granted covering neural stem cell lines
- Equity fundings raise £8.1 million before expenses
- Cash and short term investments at 31 March 2007 of £7.7 million (2006: £5.1 million)
- Loss for the year of £5.2 million (2006 restated: £6.4 million, after exceptional items of £1.2 million)
- Net cash outflow before management of liquid resources and financing items £5.4 million (2006: £4.6 million)
Commenting on the results, Professor Trevor Jones, Chairman, said:
“The period under review has been a significant one for ReNeuron, with our ReN001 stroke therapy having progressed to the point of an initial regulatory filing with the FDA in the US. We are currently supplementing this filing with further data and we remain highly confident of achieving our primary near-term objective of commencing a Phase I clinical trial with ReN001, following regulatory approval. Beyond ReN001, we have made steady progress with our other therapeutic programmes and other activities in the period, as well as further strengthening our patent estate and financial resources. We look forward to reporting further progress across all aspects of our business over the course of the current financial year.”
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. 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.
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 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
ReNeuron Group plc +44 (0)1483 302560
Financial Dynamics � Europe +44 (0)20 7831 3113
Jonathan Birt, John Capodanno
Financial Dynamics � US +1 (212) 850 5755
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.