Advanced Cell Technology, Inc. (“ACT”; OTC Bulletin Board: ACTC), a leader in the field of regenerative medicine, announced today that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has announced a positive opinion of ACT’s human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells for designation as an orphan medicinal product for the treatment of Stargardt’s disease. This opinion will now be forwarded by the EMA to the European Commission for their adoption, which should follow in coming weeks. This follows on the US Food & Drug Administration’s granting of Orphan Drug Designation for the same program from ACT, last year.
“We are very pleased to receive this positive opinion for Orphan Drug Designation from the EMA for our hESC-derived RPE cells for the treatment of Stargardt’s disease,” said Gary Rabin, ACT’s interim chairman and CEO. “There is currently no approved treatment for Stargardt’s disease, and we are working diligently to move this European trial forward as quickly as possible.”
SOURCE Advanced Cell Technology, Inc.