Stem cell therapy firm ReNeuron boosted after securing US go-ahead for blindness treatment clinical trial
08:11, 5 May 2015
By Sion Barry
ReNeuron, which is relocating to South Wales, will see its clinical trial conducted at the Massachusetts Eye and Ear centre in Boston
ReNeuron
Stem cell therapy firm ReNeuron, which is relocating from Surrey to Bridgend, has been boosted after receiving US regulatory approval for a clinical trail of its hereditary blindness therapies.
ReNeuron 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.
Last month it announced 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 it is free to begin clinical studies.
European approval
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.
US trial
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. It will involve 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.
Chief executive view
Olav Hellebø, chief executive of ReNeuron, said: "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."
08:11, 5 May 2015
By Sion Barry
ReNeuron, which is relocating to South Wales, will see its clinical trial conducted at the Massachusetts Eye and Ear centre in Boston
ReNeuron
Stem cell therapy firm ReNeuron, which is relocating from Surrey to Bridgend, has been boosted after receiving US regulatory approval for a clinical trail of its hereditary blindness therapies.
ReNeuron 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.
Last month it announced 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 it is free to begin clinical studies.
European approval
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.
US trial
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. It will involve 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.
Chief executive view
Olav Hellebø, chief executive of ReNeuron, said: "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."