Lineage Cell Therapeutics announces RG6501 study meets primary endpoint at CTS

Lineage Cell Therapeutics (LCTX) announced that 36-month results from patients enrolled in a Phase 1/2a clinical study of RG6501 in patients with geographic atrophy secondary to age-related macular degeneration, were presented at Clinical Trials at the Summit. The presentation was presented on behalf of Roche (RHHBY) and Genentech, a member of the Roche Group. Improvement in visual acuity in Cohort 4 patients was present at 12 months, 24 months, and has now persisted through 36 months. Gains in Best Corrected Visual Acuity in patients in Cohort 4 measured at month 12 remain evident through month 36 following subretinal administration of OpRegen cell therapy. Mean change in BCVA among treated eyes for patients completing three-year follow up was +6.2 letters. Improvement in BCVA and outer retinal structure in patients with extensive OpRegen bleb coverage of their GA area was greater than in patients with limited coverage and persisted through month 36. Effects were greater on average in the five patients with extensive OpRegen cell therapy coverage of atrophic areas at the time of surgical delivery. In these patients’ treated eyes, the mean change in BCVA was +9.0 ETDRS letters for those completing three-year follow-up. Sustained evidence of retinal structural improvement by a quantitative Optical Coherence Tomography analysis through 36 months was observed in treated eyes of Cohort 4 patients following a single subretinal administration of OpRegen cell therapy. At month 36, sustained evidence of retinal structure improvements in external limiting membrane and RPE drusen complex layers on OCT was observed in the subgroup of five patients in Cohort 4 with extensive OpRegen cell therapy bleb coverage of atrophic areas at the time of surgical delivery. Mean improvement of RPEDC area compared with baseline was maintained in treated eyes from 24 months to 36 months. In comparison, mean change in RPEDC area decreased in untreated fellow eyes from 24 months to 36 months. Mean change in ELM area was maintained in treated eyes from 24 months to 36 months. In comparison, mean change in ELM area decreased in untreated fellow eyes from 24 months to 36 months. These data suggest that OpRegen cell therapy may counteract RPE cell dysfunction and loss in GA by providing support to the remaining retinal cells within atrophic areas, and these effects appear durable through at least 36 months after a single administration. The Phase 2a “GAlette study” evaluating the success of subretinal delivery of OpRegen cell therapy to target areas of GA is currently enrolling. In addition to evaluating other surgical parameters, this study will test proprietary surgical devices in development for subretinal delivery of OpRegen cell therapy that have potential advantages over currently available devices and procedures.