Industry News — Clinical Updates

RPE Cell-Based OpRegen Receives Positive Results in Preclinical Studies

Cell Cure Neurosciences Ltd. (Jerusalem, Israel) has received final results from a series of preclinical safety and efficacy studies of OpRegen, retinal pigment epithelial (RPE) cells derived from human embryonic stem cells using a directed differentiation method, for treating dry AMD.

The safety data, obtained in 2 animal species, demonstrate that OpRegen cells survive for a long period of time and do not result in teratoma formation or any other type of pathology. Additionally, the cells remained therapeutically functional over long periods and maintained the animal’s visual performance, which would normally decay over time.

The studies were conducted in preparation for an investigational new drug (IND) filing with the US Food and Drug Administration (FDA) for a Phase 1/2a study of patients with geographic atrophy.

OpRegen is anticipated to be an off-the-shelf allogeneic product provided in a final formulation, ready for transplantation. Unlike treatments that require multiple injections into the eye, it is expected to be administered in a single procedure.

Updated September 17, 2014