Lineage Cell Therapeutics (LCTX) announced that its partner Genentech, a member of the Roche Group (RHHBY), has launched a Phase 2a, multicenter, open-label, single arm clinical study of RG6501 a retinal pigment epithelial cell therapy. The study is intended to optimize subretinal surgical delivery and evaluate the safety and activity of OpRegen in approximately 30, and up to 60 patients with geographic atrophy GA secondary to age-related macular degeneration. The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by Optical Coherence Tomography imaging, within 3 months following surgery. RG6501, OpRegen, is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech. "We are excited for the launch of this Phase 2a study, where one of the key objectives is to optimize the delivery of OpRegen to achieve the best outcomes," stated Seppi Lin, Vice President of OMNI Early Clinical Development at Genentech. "This study will provide key insights for the future development of the OpRegen program. Geographic Atrophy, GA , secondary to AMD is a disease area of high unmet need with no approved therapies, and we are committed to developing effective and innovative medicines for patients with serious eye diseases."
Published first on TheFly
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