RENE.L Regulatory News (RENE)

14 May 2009 10:43



PRESS RELEASE

Regulatory update

Guildford, UK, 14 May 2009: ReNeuron Group plc (LSE: RENE.L) today provides a regulatory update regarding its ReN001 stem cell therapy for stroke. In January of this year, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted regulatory approval for a Phase I clinical trial with ReN001 in disabled stroke patients, to be undertaken in Scotland at Glasgow Southern General Hospital. The decision was ratified by the Commission on Human Medicines, with the support of its Clinical Trials Expert Advisory Group which was also involved in reviewing the application.

The Company has since submitted the clinical trial application to the Gene Therapy Advisory Committee (GTAC) who, in addition to their existing gene therapy remit, were recently given responsibility to act as the national research ethics committee for stem cell therapy clinical trials in the UK. The Company has been notified by GTAC that a Provisional Opinion has been granted in respect of the application, subject to the resolution of a small number of points raised pertaining to non-safety-related pre-clinical data and the clinical trial protocol.

The Company is currently working to respond to the points raised, the majority of which involve straightforward amendments to the clinical trial protocol. Further clarification is being sought by the Company, particularly within the context of the above-mentioned regulatory approvals already received, regarding one request for further non-safety-related data by GTAC, the provision of which would potentially delay the start of the clinical trial by a few months.

Further progress updates will be given in due course. In the meantime, the Company continues with its preparations for the UK Phase I trial with ReN001, including the incorporation of the above-mentioned protocol amendments.

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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 recently 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®VM neural 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.