Date: 2015-05-04
Type of information: Presentation of results at a congress
phase: preclinical
Announcement: presentation of results at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting taking place May 3-7, 2015 , in Denver,
Company: BioTime (USA - CA) 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:
Therapeutic area: Ophtalmological diseases
Country:
Trial details:
Latest
news: * On May 4, 2015, BioTime and its subsidiary Cell Cure Neurosciences announced that preclinical data demonstrating that Cell Cure\'s product candidate, OpRegen®, preserved vision and retinal structure when transplanted into the leading animal model of retinal disease, will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting taking place May 3-7, 2015 , in Denver, Colorado . OpRegen® consists of animal product-free retinal pigment epithelial (RPE) cells with high purity and potency. The preclinical study was conducted by a scientific team led by Trevor J. McGill , Ph.D., Research Assistant Professor at the Casey Eye Institute , Oregon Health and Science University . The abstract accepted for paper presentation is titled, \"Long Term Efficacy of Xeno-free hESC-derived RPE Cells Following Transplantation into Royal College of Surgeons Rats .\" The data will be presented by Michael D. Andrews of the Casey Eye Institute , Oregon Health and Science University , and lead study investigator (Abstract 1275). Cell Cure has received regulatory clearance from the FDA and the Israeli Ministry of Health to initiate a Phase I/IIa dose escalation safety and efficacy clinical study of OpRegen® for geographic atrophy, the severe stage of the dry form of age-related macular degeneration). Patient enrollment has started at Hadassah University Medical Center in Jerusalem, Israel. Cell Cure expects to report interim data from the cohorts in the coming months.
