Lineage Cell Therapeutics (NYSE American, TASE:LCTX) presented new positive interim results from its ongoing, 24-patient Phase 1/2a clinical study of its lead product candidate, OpRegen, for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).
OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium cells administered to the subretinal space of the eye.
Additional interim data were collected on all 24 patients enrolled in the study, including 12 patients treated in Cohort 4, which feature less advanced disease, better baseline visual acuity, and smaller areas of GA.
Previously reported structural improvements in the retina and decreases in drusen density have continued with evidence of durable engraftment of OpRegen cells in some treated patients now extending to more than five years in the earliest treated patients.
A trend towards slower GA progression in treated, compared with fellow, eyes also continued, although significant changes in GA growth over a three-month period following treatment are not expected. OpRegen was well tolerated with no unexpected adverse or serious adverse events.
“Data collected from the six additional Cohort 4 patients, which we treated last fall, has reinforced our prior results and further supports that treatment with OpRegen may provide clinically meaningful outcomes in dry AMD patients with GA.,” Brian Culley, CEO of Lineage, said in a statement.
“If these early indications of a treatment effect are maintained or improve further, it will be another positive indicator for the potential of OpRegen to improve outcomes in this condition,” he added.
