RENE.L Regulatory News (RENE)

30 Jul 2009 10:05



PRESS RELEASE

ReNeuron receives UK ethics committee Favourable Opinion for stroke clinical trial

Guildford, UK, 30 July 2009: ReNeuron Group plc (LSE: RENE.L) today announces that the UK Gene Therapy Advisory Committee (GTAC) has issued a Favourable Opinion subject to conditions in respect of ReNeuron's proposed Phase I clinical trial with its ReN001 stem cell therapy for stroke. This development follows on from the earlier Provisional Opinion given by GTAC in May and is the result of further interactions between the Principal Investigator for the trial, ReNeuron and GTAC over the intervening period. GTAC acts as the national research ethics committee for gene therapy and stem cell therapy clinical trials in the UK.

Regulatory approval for the clinical trial was granted by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in January of this year, as ratified by the Commission on Human Medicines and its Clinical Trials Expert Advisory Group. The Phase I trial will take place in Scotland at Glasgow's Southern General Hospital, in patients who have been left disabled by their stroke.

The conditions attaching to the Favourable Opinion relate to clinical trial protocol amendments and the provision of supplemental, non-safety-related pre-clinical data. The Company will now work with GTAC to both clarify and address the Favourable Opinion conditions as soon as possible, prior to commencing the clinical trial.  Further updates will be given in due course.

Michael Hunt, Chief Executive Officer of ReNeuron, said:

"We are pleased to have received a Favourable Opinion on the ReN001 clinical trial from GTAC, following the prior regulatory approval by the MHRA. We now look forward to clearing the remaining hurdles attaching to the Favourable Opinion as soon as we can in order that this important UK first-in-man clinical trial can commence."

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About ReNeuron

ReNeuron is a leading, UK-based stem cell business. Its primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need.

ReNeuron has received regulatory approval to commence a Phase I clinical trial in the UK with its lead ReN001 stem cell therapy for disabled stroke patients. The Company is developing stem cell therapies for a number of other conditions, including peripheral arterial disease and diseases of the retina.

ReNeuron has also developed a range of stem cell lines for non-therapeutic applications - its ReNcell®products for use in academic and commercial research. The Company's ReNcell®CX and ReNcell®VMneural cell lines are marketed worldwide under license by USA-based 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.