LONDON (ShareCast) - (Sharecast News) - Cell-based therapeutics company ReNeuron Group updated the market on progress with the development of its human retinal progenitor cell (hRPC) therapy candidate for retinal diseases on Friday, which was currently undergoing phase 2a clinical evaluation for the treatment of the inherited blindness-causing disorder retinitis pigmentosa (RP).
The AIM-traded firm said the study was using a cryopreserved hRPC formulation, had enrolled subjects with advanced RP with some remaining central vision, and thus far had been conducted at two clinical sites in the United States.

It reported that dosing of the first cohort of three subjects in the phase 2a extension segment of the study was now complete.

That segment of the study was treating up to nine subjects with RP at a higher dose level than the first 10 subjects already treated.

In line with the clinical trial protocol, the data safety monitoring board for the study would review short-term safety data from that first cohort during the coming weeks, before the study proceeded to dosing the next cohort.

ReNeuron had previously indicated its intention to open the phase 2a study up to new sites in the US and the UK, having already received regulatory approvals to do so.

The company said the latest subject dosed in the study was treated at a new US site, the Casey Eye Institute at the Oregon Health and Science University.

As well as new sites targeted in the US and UK, an additional site in Spain was said to be "well progressed" through the regulatory process.

The company was expecting to open the ongoing phase 2a study to the site in the coming weeks.

Data from the extension segment of the phase 2a study was expected to be presented later in the year, once all remaining subjects had been treated.

The firm said it expected that the expanded study would generate sufficient data to enable it to begin a single pivotal clinical study in the second half of 2022 with its hRPC cell therapy candidate in RP.

It said the pivotal study would be designed to demonstrate further the safety and efficacy of the treatment and, assuming a successful outcome, enable ReNeuron to seek marketing approvals for its hRPC cell therapy candidate in RP in selected major markets.

The board noted that the programme had been granted orphan drug designation in both Europe and the US, as well as fast track designation from the US Food and Drug Administration (FDA).

"We are extremely pleased to have completed dosing of the first subject cohort in the extended phase 2a clinical study with our hRPC cell therapy candidate in RP patients," said chief executive officer Olav Hellebø.

"We are excited that one of the subjects was treated at a new clinical site in the US and we hope to add further new clinical sites shortly.

"The study continues to proceed according to plan."

At 1211 GMT, shars in ReNeuron Group were up 13.16% at 129p.

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