ReNeuron Provides Regulatory Update On Stroke Drug

On 11 January, ReNeuron announced that it 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.

In response to the submission, the company has received written confirmation from GTAC that the above data package has been reviewed and that this principal condition has been satisfied.

ReNeuron 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 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.

The company is expecting to receive an unconditional favourable opinion from GTAC in respect to the ReN001 phase I clinical trial shortly, enabling the trial to commence thereafter.