FDA Approves Start of Phase I/II Clinical Trial in the US
News May 05, 2015
ReNeuron Group plc has announced that it has received regulatory approval from the US Food and Drug Administration (FDA) to commence a Phase I/II clinical trial in the US with its human Retinal Progenitor Cell (hRPC) therapy candidate for retinitis pigmentosa (RP). RP is a group of hereditary diseases of the eye that lead to progressive loss of sight due to cells in the retina becoming damaged and eventually dying.
The Company has announced on 13 April 2015 that it had filed an Investigational New Drug (IND) application with the FDA to commence the Phase I/II clinical trial. The Company has since received notification from the FDA that the review of the application is complete and that ReNeuron is free to begin clinical studies.
ReNeuron’s cell therapy candidate for RP has already been granted Orphan Drug Designation in both Europe and the US by the European Commission and the FDA, respectively.
The Phase I/II clinical trial will be conducted at Massachusetts Eye and Ear, Boston, a world-renowned clinical centre for the treatment of retinal diseases. The trial design is an open-label, dose escalation study to evaluate the safety, tolerability and preliminary efficacy of the hRPC stem cell therapy candidate in up to 15 patients with advanced RP. Preparations for the study have commenced and ReNeuron expects the study to begin in the second half of this year.
Olav Hellebø, Chief Executive Officer of ReNeuron, commented: “We are delighted to have received regulatory approval to commence our first clinical trial in the US with our hRPC stem cell therapy candidate for RP. It is a testament both to our staff and to the quality of our hRPC technology that this first-in-man clinical trial application was approved so promptly. We are delighted to be working with Massachusetts Eye and Ear on this important clinical trial and we look forward to initiating the study later this year.”