Date: 2014-09-17
Type of information: Results
phase: preclinical
Announcement: results
Company: BioTime (USA - CA) HBL Hadasit Bio-Holdings (Israel) Cell Cure Neurosciences (Israel)
Product: OpRegen®
Action
mechanism: cell therapy. OpRegen® consists of retinal pigment epithelial cells (RPE) derived from human embryonic stem cells using a proprietary directed differentiation method. OpRegen® is formulated as a suspension of RPE cells. Preclinical studies in mice have shown that OpRegen® transplanted subretinally as a suspension of cells can rapidly organize into their natural monolayer structure and survive throughout the lifetime of the animal. OpRegen® will be an \"off-the-shelf\" allogeneic product provided to retinal surgeons in a final formulation ready for transplantation. Unlike treatments that require multiple injections into the eye, such as currently-marketed products like Lucentis and Eylea for wet-AMD, it is expected that OpRegen® will be administered in a single procedure.
Disease: dry form age-related macular degeneration (dry-AMD)
Therapeutic area: Ophtalmological diseases
Country:
Trial details:
Latest
news: * On September 17, 2014, BioTime, HBL Hadasit Bio-Holdings and Cell Cure Neurosciences announced that Cell Cure has received the final results of a series of extensive preclinical safety and efficacy studies of its development-stage product designated OpRegen®, which is intended for use in the treatment of dry form age-related macular degeneration (dry-AMD). These studies were conducted by Cell Cure and contract research organizations in preparation for an IND filing with the FDA for a Phase 1/2a study in patients with geographic atrophy, the severe stage of dry-AMD. The efficacy of the OpRegen® cells was evaluated in the Royal College of Surgery rat model of retinal degeneration. The OpRegen® cells were found to remain therapeutically functional over long periods and to maintain the animal\'s visual performance that would normally decay over time in this disease model. Cell Cure is now looking forward to initiating the clinical trial that will utilize high quality, xeno-free grade RPE cells for the treatment of geographic atrophy, the severe stage of dry-AMD.
