ReNeuron has worked with collaborators and academic institutions in the retinal disease field to successfully take its retinitis pigmentosa programme through pre-clinical development. These include the Schepens EyeResearch Institute/Massachusetts Eyeand Ear (an affiliate of Harvard Medical School), UCL Institute of Ophthalmology, MoorfieldsEye Hospital and the US-based Foundation Fighting Blindness.
The pre-clinical program has also benefited from UK Government funding under a BioMedical Catalyst grant, awarded in 2013. Pre-clinical studies carried out in disease models by the Company’s academic collaborators have demonstrated that, when transplanted into the retina, the retinal progenitor cell technology has 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.
The proposed Phase I/II clinical trial will be conducted at Massachusetts Eye and Ear, Boston, with Dr Eric Pierce, Director, Retinal Degenerations Service at Massachusetts Eye and Ear, will be the Principal Investigator for the clinical trial.
The trial design is an open-label, dose escalation study to evaluate the safety, tolerability and preliminary efficacy of the hRPC stem cell therapy candidate in up to 15 patients with advanced RP. The method of administration of the hRPCs will be a single sub-retinal injection. The primary endpoint of the study is safety, with patients being followed up for 12 months post-treatment with monitoring including measurements of visual acuity. Subject to regulatory and local ethics approvals, ReNeuron expects to be able to commence the clinical trial in the second half of this year.
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