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ReNeuron Progressing Blindness Candidate Through Phase I/II Trial

Wed, 08th Jun 2016 08:36

LONDON (Alliance News) - ReNeuron Group PLC on Wednesday said it was making progress with its Phase I/II dose escalation study of its human retinal progenitor cell therapy candidate in patients with advanced retinitis pigmentosa in the US.

ReNeuron's cell therapy candidate aims to halt blindness, and potentially restore vision, to patients who have advanced retinitis pigmentosa, an inherited degenerative eye disease.

ReNeuron said the third and last patient in the first dose cohort of the study is now scheduled for treatment within the next week, with the second patient having been treated following a positive Data Safety Monitoring Board review of one month follow-up data from the first patient treated in this cohort.

The Phase I/II clinical trial is evaluating the safety, tolerability and preliminary efficacy of ReNeuron's therapy candidate.

Initial short-term safety and tolerability data from the Phase I part of the study in the first nine patients are expected in early 2017, ReNeuron said, whilst longer-term safety data, as well as efficacy read-outs from the Phase II part of the study in a further six patients, are expected in the second half of 2017.

Subject to the outcome of this, ReNeuron said it expects to file an application in late 2017 or early 2018 to commence a Phase II/III trial.

ReNeuron shares were up 3.7% at 3.50 pence Wednesday.

By Hannah Boland; hannahboland@alliancenews.com; @Hannaheboland