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ReNeuron Group Updates Regarding ReN001 Stem Cell Therapy For Stroke And ReN009 Stem Cell Therapy For Peripheral Arterial Disease

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

ReNeuron Group plc (RENE.L) provided a regulatory update regarding its ReN001 stem cell therapy for stroke and its ReN009 stem cell therapy for peripheral arterial disease or PAD. In December, the Company finalised and submitted the supplemental pre-clinical data package requested by the UK Gene Therapy Advisory Committee or 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.

The company has made further advances with its ReN009 programme for PAD. The Company said that it 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.

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