Date: 2016-07-22
Type of information: Publication of results in a medical journal
phase: preclinical
Announcement: publication of results in Translational Vision Science & Technology (TVST)
Company: Reneuron (UK)
Product: human Retinal Progenitor Cell (hRPC) therapy
Action mechanism: stem cell therapy
Disease: retinitis pigmentosa
Therapeutic area: Ophtalmological diseases
Country:
Trial details:
Latest news: • On July 22, 2016, ReNeuron , a UK-based global leader in the development of cell-based therapeutics, announced the publication in the journal Translational Vision Science & Technology (TVST) of further key pre-clinical efficacy data with its human retinal progenitor cells (hRPCs) (Semo et al. Translational Vision Science & Technology July 2016, Vol.5, 6. doi:10.1167/tvst.5.4.6). This paper describes work undertaken in conjunction with ReNeuron's research collaborators at UCL Institute of Ophthalmology, London, and Schepens Eye Research Institute of Massachusetts Eye and Ear, Boston, US. The studies assessed the long-term efficacy and safety of ReNeuron's hRPCs using established pre-clinical rodent models and gave positive results. The hRPCs were well tolerated, safe and preserved retinal structure and vision up to six months post-injection in the studies. The cells also survived and integrated into both damaged and normal neural retina without adverse affects. These findings suggest that, as well as treating later stage retinal disease, the hRPCs can be deployed in less affected regions of the retina at earlier stages of retinal disease or even in normal regions of peripheral retina. ReNeuron has used the above pre-clinical data, as well as earlier, positive pre-clinical data to support the clinical development of its hRPC cell therapy candidate, initially in patients with retinitis pigmentosa. A Phase I/II clinical trial has recently commenced in the US to evaluate the safety, tolerability and preliminary efficacy of the hRPCs in patients with retinitis pigmentosa. The study is being conducted at Massachusetts Eye and Ear in Boston, a teaching affiliate of Harvard Medical School. As previously announced, 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. Reneuron looks forward to reporting data from the ongoing US Phase I/II clinical trial in RP patients during the course of 2017.
