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Positive results seen in fourth cohort of OpRegen phase 1/2a study
Based on positive early data available for the first five patients in a phase 1/2a clinical study of OpRegen, Lineage Cell Therapeutics announced it would open new clinical sites to accelerate patient enrollment.
OpRegen is under study as a retinal epithelium transplant therapy in patients with advanced dry age-related macular degeneration with geographic atrophy. The study aims to evaluate the safety and efficacy of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line in 24 patients divided into four cohorts. The first three cohorts included patients who were legally blind with best corrected visual acuity of 20/200 or worse. The fourth cohort consists of 12 patients with better baseline vision and represents the company’s intended population, according to a press release.
The study’s data safety monitoring board removed the protocol-mandated treatment stagger, allowing Lineage to accelerate patient enrollment and open new clinical sites at Cincinnati Eye Institute and Wills Eye Hospital. Patients in cohort four have less advanced disease and smaller areas of geographic atrophy than patients in cohorts one through three, according to the release.
All five patients in cohort four have shown increased BCVA. One patient in cohort four was dosed with a thaw-and-inject formulation via a new subretinal delivery system from Gyroscope Therapeutics and at 6 months after treatment gained five lines of vision, improving from 20/250 at baseline to 20/100 in the treated eye.