palucorcel (CNTO 2476) / J&J - LARVOL DELTA

PRELUDE: A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy (clinicaltrials.gov) - P2 | N=21 | Completed | Sponsor: Janssen Research & Development, LLC | Phase classification: P2b ➔ P2

Phase classification • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

PRELUDE: A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy (clinicaltrials.gov) - P2; N=255; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

New P2 trial • Biosimilar • Complement-mediated Rare Disorders • Gene Therapies • Ophthalmology

PRELUDE: A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy (clinicaltrials.gov) - P2b; N=255; Recruiting; Sponsor: Janssen Research & Development, LLC; Phase classification: P2 ➔ P2b

Phase classification • Age-related Macular Degeneration • Biosimilar • Complement-mediated Rare Disorders • Gene Therapies • Ophthalmology

Efficacy and Safety Study of CNTO 2476 in Participants With Visual Acuity Impairment Associated With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD) (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Janssen Pharmaceutical K.K.; Initiation date: Mar 2017 ➔ Apr 2018

Trial initiation date • Age-related Macular Degeneration • Biosimilar • Complement-mediated Rare Disorders • Gene Therapies • Ophthalmology

Safety and Efficacy of Subretinally Administered Palucorcel for Geographic Atrophy of Age-Related Macular Degeneration: Phase 2b Study. (PubMed, Ophthalmol Retina) - "Palucorcel was delivered successfully to the targeted subretinal site using a novel delivery system and suprachoroidal approach for most participants; however, improvement in GA area, retardation of growth, or visual acuity were not demonstrated."

Clinical • Journal • P2b data

Subretinal Human Umbilical Tissue-Derived Cell Transplantation Preserves Retinal Synaptic Connectivity and Attenuates Müller Glial Reactivity. (PubMed, J Neurosci) - "Human umbilical tissue-derived cells (hUTC or palucorcel) are currently under clinical investigation for the treatment of geographic atrophy, a late stage of macular degeneration, but how hUTC transplantation mediates vision recovery is not fully elucidated...hUTC transplantation strongly attenuates the reactivity of Müller glia in RCS rats. These findings highlight novel cellular and molecular mechanisms within the neural retina which underlie disease mechanisms and pinpoint Müller glia as a novel cellular target for hUTC transplantation."

Journal

PRELUDE: A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy (clinicaltrials.gov) - P2b; N=21; Completed; Sponsor: Janssen Research & Development, LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion