Retinitis Pigmentosa Trial Progresses To Next Stage In U.S.
BRIDGEND, U.K., March 18, 2019 -- British cell-based therapeutics company ReNeuron Group plc (AIM: RENE) announced further progress with the ongoing Phase 1/2 clinical trial in the U.S. of its hRPC cell therapy candidate in the blindness-causing disease, retinitis pigmentosa (RP).
The reported that a positive Data Safety Monitoring Board (DSMB) review of the data from the first Phase 2 patient cohort permitted dosing of the second cohort of three Phase 2 subjects.
The first patient in the cohort was treated earlier in the month at Harvard's 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.
That provides 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 2 cohort.
Last month, the company reported that all three of the first cohort of subjects in the Phase 2 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.
The company's RP clinical program benefits from Orphan Drug Designation in both Europe and the U.S., as well as fast track designation from the FDA.
The company expects to report further shortterm read-outs in mid-2019 from the ongoing Phase 1/2 study.
"We remain extremely encouraged by the positive efficacy data we have seen thus far in the Phase 1/2 study with our hRPC cell therapy candidate in RP patients," said CEO Olav Hellebe. "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."