Regulatory Update

ReNeuron Group plc 03 January 2008 PRESS RELEASE Regulatory update Guildford, UK, 3 January 2008: ReNeuron Group plc (LSE: RENE.L) today provides an update on progress with its Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to commence initial clinical trials in the US with its ReN001 stem cell therapy for stroke. On 3 December 2007, the Company announced that it had submitted its responses to the requests made by the FDA in respect of the original IND application. The Company has subsequently been notified that the IND currently remains on clinical hold. Whilst most of the substantive issues raised by the FDA in the original IND hold letter have been satisfactorily addressed in the amended IND package, there are a small number of further hold issues that remain to be resolved. The Company intends to meet with the FDA shortly to discuss and agree an approach to resolving these remaining issues in a timely fashion. Further announcements will be made by the Company in due course. In the meantime, the Company is continuing its preparations for the clinical phase of development of its ReN001 therapy. As mentioned in the Company's recent interim results statement, these preparations include continuing dialogue with regulatory authorities in other key territories such as the UK, with a view to further clinical trial applications in these territories in due course. Michael Hunt, Chief Executive Officer of ReNeuron, said: 'We look forward to continuing our dialogue with the FDA and other regulatory authorities regarding ReN001. Given the ground-breaking nature of this therapy and the lack of clinical precedent, it is not surprising that the FDA is adopting a cautious and thorough approach in its review of the IND data package. That said, and based on the proof-of-concept, safety and product manufacturing data package that we have and are continuing to build for ReN001, we remain confident that this therapy can be taken into the clinic this year.' Enquiries: ReNeuron Michael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302560 Dr John Sinden, Chief Scientific Officer Financial Dynamics Europe David Yates Tel: +44 (0) 20 7831 3113 Lara Mott US Robert Stanislaro Tel : +1 212 850 5657 About ReNeuron 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. The Company operates from laboratories in Surrey, UK and Los Angeles, California, USA. 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. In addition to its stroke programme, ReNeuron is developing stem cell therapies for Parkinson's disease, Huntington's disease, Type 1 diabetes and diseases of the retina. The Company recently announced the acquisition of the business assets of AmCyte Inc. in the US, bringing clinically-tested cell encapsulation technology to ReNeuron's ReN002 diabetes programme. ReNeuron has leveraged its stem cell technologies into non-therapeutic areas - its ReNcell(R) range of cell lines for use in research and in drug discovery applications in the pharmaceutical industry. ReNeuron's ReNcell(R)CX and ReNcell(R)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. This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as 'should', 'expects', 'estimates', 'believes' or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron's actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements This information is provided by RNS The company news service from the London Stock Exchange
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