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.
