26th Mar 2018 15:53
The company said it has continued preparations to commence a Phase IIb clinical study in the US with its CTX cell therapy candidate for stroke disability. The study, designated PISCES III, is a randomised, placebo-controlled clinical trial in 110 patients.
The primary end-point of the study will be a comparison of the proportion of patients in the treated and placebo arms showing a clinically important improvement on the modified Rankin Scale at 6 months post-treatment compared with baseline.
ReNeuron said it has decided to increase the number of clinical sites in the PISCES III study from 25 to 40 in order to ensure that patient recruitment targets in the study are met.
On this basis, and assuming the initial sites in the study are open for recruitment in the second quarter of this year, following local ethics approvals, the company expects first patient dosing in mid-2018 and top-line data from the study, as previously indicated, in late 2019.
Additionally, ReNeuron said four cohorts of three patients each have been dosed in the ongoing US Phase I/II clinical trial of our hRPC cell therapy candidate for the blindness-causing inherited retinal disease, retinitis pigmentosa.
The study is an open-label, dose escalation study to evaluate the safety, tolerability and preliminary efficacy of its hRPC stem cell therapy candidate in patients with advanced RP.
ReNeuron said it now expects the hRPC therapy to be most effective in RP patients with a sufficiently intact retina to enable good engraftment of the hRPC cells and subsequent generation of functional photoreceptors.
The company is therefore extending the study in order to expand the safety database in patients with less impaired vision than those treated thus far. The firm expects short-term read-outs from the ongoing Phase I/II clinical trial later than originally planned, in the first half of 2019, with the Phase IIb study commencing shortly thereafter.
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