Data From BioTime’s Phase 1/2a OpRegen Trial to be Presented at the 2017 AAO Annual Meeting

Source: BioTime

Wednesday, July 19, 2017 | Clinical Trials , AMD , BioTime


BioTime announced that an abstract related to the company’s retinal tissue implant has been accepted for a paper presentation at the American Academy of Ophthalmology (AAO) annual meeting being held in New Orleans, November 11-14.

The abstract accepted for paper presentation is titled, “Phase 1 and 2a Study of Human Embryonic Stem Cell–Derived Retinal Pigment Epithelial Cells Transplanted Subretinally in Advanced Dry-Form AMD Patients.” The data will be presented by Oscar Cuzzani, MD, PhD, BioTime’s Vice President of Clinical Development. With more than 30 years of experience as a physician and in clinical development, Dr. Cuzzani has a wealth of experience practicing retinal surgery, and has held senior level positions working at some of the best research organizations including the National Eye institute and the Bascom Palmer Eye Institute.

“The clinical work that our team, along with the principal investigators and other leading ophthalmologists, is conducting is of great importance for the millions of patients suffering from this debilitating disease and leading cause of blindness among the elderly population,” Adi Mohanty, Co-Chief Executive Officer, said in a company news release. “This is a significant opportunity to broaden awareness among clinicians about the significant progress of the OpRegen program.”

The company announced data from the phase 1/2a clinical trial of OpRegen at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in May. The presentation reported new clinical trial data with two patients that were treated in cohort 2, where they received a dose of 200,000 cells. Imaging analysis suggests the transplanted OpRegen cells remained in place (engrafted) in an area of the scar that was completely depleted of retinal pigment epithelium (RPE) because of the advanced stages of the disease. Cell engraftment appears evident in four of the five patients treated thus far. There was also possible evidence of a biological response with some areas appearing to show structural improvement (a thickening of the area of the neural retina above the scar) without any signs of retinal edema, a fluid build-up that can further compromise vision.

OpRegen is now in a phase 1/2a dose finding study to evaluate its safety and efficacy in patients who have an advanced stage of the disease, and has received fast track designation by the FDA.


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