ReNeuron Group’s Retinitis Pigmentosa Phase I/II Clinical Trial Moving Forward
ReNeuron Group’s Clinical trial is progressing and they have set it’s third and last patient to halt the progression of Retinitis Pigmentosa. Researchers at Massachusetts Eye and Ear in Boston are using human retinal progenitor cells (hRPC) for this. Retinitis Pigmentosa is an eye disease that leads to retinal degeneration, that eventually lead to blindness
ReNeuron Group plc, a UK-based stem cell therapy development company, has provided an update on progress with the currently going US Phase I/II dose escalation study of its human retinal progenitor cell (hRPC) therapy candidate in patients with advanced retinitis pigmentosa (RP).
The Company reported that the third and last patient in the first dose cohort of the study is scheduled for treatment. This is scheduled within the next week and they are hoping for positive results. The second patient was recently treated following a positive Data Safety Monitoring Board review of one month follow-up data from the first.
As stated via official news,
Initial short-term safety and tolerability data from the Phase I part of the study in the first nine patients are expected in early 2017. Longer-term safety data, as well as efficacy read-outs from the Phase II part of the study in a further six patients, are expected in the second half of 2017. Subject to the outcome of the Phase I/II study, we expect to be able to file an application in late 2017 or early 2018 to commence a pivotal Phase II/III clinical trial of hRPC in RP. A positive outcome from this study is expected to form the basis for subsequent marketing authorisation filings in both the US and Europe.
The Phase I/II clinical trial is assessing the safety, tolerability and preliminary efficacy of ReNeuron’s hRPC cell therapy candidate in RP patients.
ReNeuron is also hosting an event to discuss the field with key opinion leaders in retinal disease. Also, it will focus on its retinitis pigmentosa programme. The event will held in the US on 13 June 2016.
Study conducted at: Massachusetts Eye and Ear in Boston, a teaching affiliate of Harvard Medical School (HMS). Principal Investigator of the study: Dr. Eric Pierce, MD, PhD, Director of the Ocular Genomics Institute and Berman Gund Laboratory for Study of Retinal Degenerations at Massachusetts Eye and Ear and HMS.
