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ReNeuron treats first Oxford patient as part of expanded study
18th Oct 2021 09:14
(Sharecast News) - Cell-based therapeutics developer ReNeuron Group said on Monday that the first UK subject had been treated at the Oxford Eye Hospital as part of its phase 2a clinical evaluations for the treatment of retinitis pigmentosa (RP) - an inherited, degenerative eye disease.
The AIM-traded firm said the remaining study subjects were expected to be treated by the end of 2021.
It explained that its hRPC therapeutic candidate was undergoing phase 2a clinical evaluations for the treatment of retinitis pigmentosa (RP), which affects 1 in 4,000 people in the United States and worldwide.
The expanded study encompassed four sites worldwide, with two sites in the US as well as the recently-activated sites in the UK and in Spain.
ReNeuron saud the study used a cryopreserved human retinal progenitor cell line (hRPC) formulation, enrolling subjects with advanced RP with some remaining central vision.
The two million cell dose used in the study extension represented a doubling of the earlier dose level, where good product safety and efficacy signals were seen in subjects followed out to 12 months.
As it previously announced, the company was expecting to present early efficacy data from the extension segment of the study in the first quarter of 2022.
ReNeuron said it was on track to advance the programme into the next clinical trial by the end of 2022.
"We are extremely pleased to see the first subject dosed in the UK in this phase 2a clinical evaluation for our hRPC therapeutic candidate and expect to complete dosing of the remaining subjects in the expanded segment of the study by the end of 2021," said chief executive officer Olav Hellebø.
"We are proud to be working with the University of Oxford, a team globally renowned for cutting edge retinal disease research.
"We look forward to updating the market in the first quarter of next year on early efficacy data from the expanded phase 2a study."
At 0840 BST, shares in ReNeuron Group were up 1.72% at 118.5p.
The AIM-traded firm said the remaining study subjects were expected to be treated by the end of 2021.
It explained that its hRPC therapeutic candidate was undergoing phase 2a clinical evaluations for the treatment of retinitis pigmentosa (RP), which affects 1 in 4,000 people in the United States and worldwide.
The expanded study encompassed four sites worldwide, with two sites in the US as well as the recently-activated sites in the UK and in Spain.
ReNeuron saud the study used a cryopreserved human retinal progenitor cell line (hRPC) formulation, enrolling subjects with advanced RP with some remaining central vision.
The two million cell dose used in the study extension represented a doubling of the earlier dose level, where good product safety and efficacy signals were seen in subjects followed out to 12 months.
As it previously announced, the company was expecting to present early efficacy data from the extension segment of the study in the first quarter of 2022.
ReNeuron said it was on track to advance the programme into the next clinical trial by the end of 2022.
"We are extremely pleased to see the first subject dosed in the UK in this phase 2a clinical evaluation for our hRPC therapeutic candidate and expect to complete dosing of the remaining subjects in the expanded segment of the study by the end of 2021," said chief executive officer Olav Hellebø.
"We are proud to be working with the University of Oxford, a team globally renowned for cutting edge retinal disease research.
"We look forward to updating the market in the first quarter of next year on early efficacy data from the expanded phase 2a study."
At 0840 BST, shares in ReNeuron Group were up 1.72% at 118.5p.