PISCES III is a phase IIb clinical study in the US of ReNeuron’s CTX cell therapy candidate for stroke disability.
ReNeuron said it had taken the decision to increase the number of sites to ensure that patient recruitment targets in the study are met.
First patient dosing in the study is expected in mid-2018 and top-line data from the study, as previously indicated, is expected in late 2019.
The group also updated the market on its hRPC stem cell therapy candidate for retinal diseases and its exosome nanomedicine platform.
hRPC stem cell therapy candidate for retinal diseases
Four cohorts of three patients each have been dosed in the ongoing US phase I/II clinical trial for the blindness-causing inherited retinal disease, retinitis pigmentosa (RP).
ReNeuron said it now expects its hRPC therapy to be most effective in RP patients with sufficiently intact retina to enable good grating of the hRPC cells and subsequent regeneration of functional photoreceptors.
As a result, it is now extending the study to expand the safety database in patients with less impaired vision than those treated thus far.
This patient group will be targeted in a subsequent clinical trial, which, as previously flagged, will be a controlled phase IIb study.
The expanded phase I/II study will allow ReNeuron to optimise the formulation and dosing of the hRPC therapy ahead of the start of the subsequent study.
Based on the above, ReNeuron expects short-term read-outs from the ongoing phase I/II clinical trial in the first half of 2019, which is later than originally planned, with the phase IIb study commencing shortly thereafter.
Exosome nanomedicine platform
Pre-clinical development work continues with ExoPr0, ReNeuron’s first CTX-derived exosome therapeutic candidate.
Subject to continued success with ongoing pre-clinical development work, ReNeuron hopes to be able to commence clinical development with ExoPr0 during 2019, as previously indicated, targeting a solid tumour cancer indication.