RENE.L Regulatory News (RENE)

28 Jan 2010 07:00



PRESS RELEASE

Regulatory update

Guildford, UK, 28 January 2010: ReNeuron Group plc (LSE: RENE.L) today provides a regulatory update regarding its ReN001 stem cell therapy for stroke.

On 11 January, the Company announced that it had finalised and submitted the supplemental pre-clinical data package requested by the UK Gene Therapy Advisory Committee (GTAC) in support of the Company's proposed Phase I clinical trial with ReN001. This data package was submitted to GTAC in response to the principal condition attaching to GTAC's conditional favourable ethical opinion already given with regard to the proposed clinical trial.

The Company is pleased to announce that it has received written confirmation from GTAC that the above data package has been reviewed and that this principal condition has now been satisfied.

The Company is now in the process of submitting the final signed versions of the amended clinical trial protocol and associated documents for GTAC's remaining review and approval. The amendments made to these documents arise from the other conditions imposed by GTAC in giving their conditional favourable opinion, conditions which do not involve the provision of further data and which the Company and the Principal Investigator for the trial have accepted and incorporated into the clinical trial protocol in full. The UK Medical and Healthcare products Regulatory Agency (MHRA) have also separately approved these clinical trial protocol amendments.

On the basis of the above, the Company is confident of receiving an unconditional favourable opinion from GTAC in respect of the ReN001 Phase I clinical trial very shortly, enabling the trial to commence thereafter.

Enquiries:

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 and conditional ethical approvals 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.

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.