Guildford, UK, 11 January 2010: ReNeuron Group plc (LSE: RENE.L) today provides a regulatory update regarding its ReN001 stem cell therapy for stroke and its ReN009 stem cell therapy for peripheral arterial disease (PAD).
ReN001
In December, the Company 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 a condition attaching to GTAC’s final favourable ethical opinion already given with regard to the proposed clinical trial. The package contains data from further pre-clinical studies demonstrating the positive functional effects of the ReN001 cells and the mechanisms by which the cells engender these positive effects in relevant disease models. The results of these studies consequently impact favourably on the risk-benefit profile of the ReN001 therapy by providing further evidence of the potential clinical benefits that the therapy may bring to disabled stroke patients.
These new pre-clinical studies with ReN001 were conducted over recent months by leading academic researchers in the field and the key data from the studies will be submitted for presentation and publication in due course.
Assuming a swift and successful review process resulting from this submission, the Company maintains its target of commencing the ReN001 Phase I clinical trial in the UK in the first quarter of this year.
ReN009
The company has made further advances with its ReN009 programme for PAD. Following the presentation of positive pre-clinical efficacy data with ReN009 at the recent American Heart Association meeting, the Company has taken scientific advice meetings with both GTAC and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in order to discuss and agree certain aspects of the late pre-clinical development plan for this therapy. The Company is encouraged by the feedback it has now received from both of these meetings, with no substantive or unforeseen issues raised based on the data provided to these regulatory bodies.
The Company is now proceeding with late pre-clinical testing of the ReN009 therapy and will continue to liaise with the regulatory authorities both in the UK and in other territories, including the US, ahead of the commencement of initial clinical trials next year.
