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news.US-based BioTimeCell subsidiary Cure Neurosciences has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) seeking to begin a Phase I/IIa clinical trial of OpRegen in patients with geographic atrophy (GA).
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GA is the severe stage of the dry form of age-related macular degeneration (dry-AMD).
OpRegen includes retinal pigment epithelial (RPE) cells derived from human embryonic stem cells and is intended to be given as a single dose into the subretinal space of patients’ eyes in order to treat this leading cause of blindness.
The design of the proposed clinical trial is based on a pre-IND meeting with the FDA and a series of earlier interactions with the agency.
The company said that patients will undergo a single transplantation and the trial will explore three different doses of OpRegen.
After transplantation, the patients will be followed over 12 months at specified intervals and then at longer time periods, to assess the safety and tolerability of the product.
The secondary objective of the trial will be to explore the ability of transplanted OpRegen to engraft, survive, and moderate the disease progression.
Cell Cure CEO Charles Irving said the filing of this IND is the culmination of 12 years of research and development starting at the Hadassah Human Embryonic Stem Cell Research Center at Hadassah University Medical Center, Jerusalem, Israel, under the direction of Prof. Benjamin Reubinoff, MD, PhD and continuing at Cell Cure Neurosciences.
"We look forward to initiating the clinical trial that will, for the first time, utilize xeno-free grade human embryonic stem cell derived RPE cells with high purity and potency, for the treatment of geographic atrophy, the severe stage of dry-AMD," Irving said.