ReNeuron provided an update to its ongoing phase I/II trial evaluating Human Retinal Progenitor Cells (hRPC’s) in the blindness-causing disease, retinitis pigmentosa. The company reported that dosing of the second cohort of three subjects in the phase II portion of the trial has commenced. This announcement follows a positive Data Safety Monitoring Board (DSMB) review of the clinical data from the first Phase II patient cohort in the study. This next dose cohort comprises patients who have a greater baseline level of visual acuity than those treated in the study thus far, thus providing a framework to better evaluate the safety of the treatment and to gain further clarity on the strong efficacy signal that was seen in the first Phase II cohort.
Last month, ReNeuron reported that all three of the first cohort of subjects in the Phase II part of the study had reported a rapid and significant improvement in vision, on average equivalent to reading an additional three lines of 5 letters on the EDTRS eye chart, the standardized eye chart used in clinical trials to measure visual acuity. ReNeuron expects to report further short term read-outs in mid-2019 from the ongoing Phase I/II study. Source
About Retinitis Pigmentosa
Retinitis Pigmentosa (RP) is a hereditary disease of the eye that lead to progressive loss of vision due to cells in the retina becoming damaged and eventually dying. In RP, there is a progressive loss of rod cells in the periphery of the retina causing night blindness that leads to loss of peripheral vision, and ultimately tunnel vision.
About Human Retinal Progenitor Cells (hRPC’s)
Pre-clinical studies have demonstrated that retinal implantation of human retinal progenitor cells (hRPC) have the potential to preserve existing photoreceptors, potentially reducing or halting further deterioration of vision. In addition, the progenitor cells have been shown to mature into functional photoreceptors that engraft into the photoreceptor layer, bringing the possibility of restored vision.
ReNeuron’s RP clinical program benefits from Orphan Drug Designation in both Europe and the US, as well as Fast Track designation from the FDA.