BioTime (NYSE MKT:BTX) is expanding its ongoing Phase 1/2a clinical trial for OpRegen in the advanced dry form of AMD by naming the first two sites that will treat patients in the U.S.
“The addition of U.S. clinical trial sites is an important step in the acceleration of our clinical development program for OpRegen,” Adi Mohanty, co-CEO, said in a statement.
The sites are currently going through the set-up process. BioTime anticipates enrolling and treating U.S.-based patients by the end of the second quarter.
The company will be working with two of the leading U.S. clinicians in ophthalmology: Dr. David Boyer and Dr. Richard McDonald. Dr. Boyer, is a senior partner with Retina-Vitreous Associates Medical Group in Los Angeles.
Dr. McDonald is a senior partner at West Coast Retina Medical Group in San Francisco.
OpRegen is an investigational therapy in which retinal pigment epithelial (RPE) cells are introduced into the subretinal space where they are intended to replace missing RPE cells. The ongoing dose escalation study is evaluating the safety and efficacy of three different dose regimens of OpRegen in patients with the advanced form of dry-AMD accompanied by geographic atrophy.
Data recently presented from the first patient cohort indicate that at the first dose, OpRegen caused no serious adverse events, and retinal imaging suggests the presence and survival of transplanted cells in the subretinal space for up to one year.