BlueRock Therapeutics LP, a clinical stage cell therapy company and subsidiary of Bayer AG, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for OpCT-001, an investigational induced pluripotent stem cell (iPSC)-based cell therapy for the treatment of primary photoreceptor diseases. Discoveries over the past 15 years by the lab of David Gamm, MD, PhD, established the potential for pluripotent stem cells to produce an unlimited supply of authentic human photoreceptors. Subsequent establishment of Opsis Therapeutics by Gamm and Fujifilm Cellular Dynamics Inc. (Madison, WI) resulted in successful clinical grade production of human photoreceptors (OpCT-001), which were exclusively licensed by BlueRock Therapeutics. This investigational therapy, which targets a subgroup of inherited retinal disorders that includes retinitis pigmentosa and cone-rod dystrophies, will now be tested in an upcoming clinical trial.
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