Retinal clinical trial progresses to next stage
ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to announce a further update on progress with the ongoing Phase I/II clinical trial in the US of its hRPC cell therapy candidate in the blindness-causing disease, retinitis pigmentosa (RP).
The Company is pleased to report that, following a positive Data Safety Monitoring Board (DSMB) review of the clinical data from the first Phase II patient cohort in the study, dosing of the second cohort of three Phase II subjects has now commenced, with the first subject in the cohort treated last week at Massachusetts Eye and Ear, in Boston. 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, the Company 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 standardised eye chart used in clinical trials to measure visual acuity.
The Company’s RP clinical programme benefits from Orphan Drug Designation in both Europe and the US, as well as Fast Track designation from the FDA. As previously reported, the Company expects to report further short term read-outs in mid-2019 from the ongoing Phase I/II study.
“We remain extremely encouraged by the positive efficacy data we have seen thus far in the Phase I/II study with our hRPC cell therapy candidate in RP patients. These results have already attracted considerable interest, particularly from those in the ophthalmology field, and we look forward to reporting further results from the study as it progresses over the coming months.”