BioTime Expands OpRegen® Clinical Trial in Dry-AMD With Opening of First US Sites
ALAMEDA, Calif.–(BUSINESS WIRE)–BioTime, Inc. (NYSE MKT:BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today announced the expansion of its ongoing Phase I/IIa clinical trial for OpRegen® in the advanced dry form age-related macular degeneration (dry-AMD) by naming the first two sites that will treat patients in the U.S.
“I am excited about the potential of BioTime’s OpRegen® for the treatment of dry-AMD, the leading cause of blindness in the elderly”
“The addition of U.S. clinical trial sites is an important step in the acceleration of our clinical development program for OpRegen®,” commented Adi Mohanty, Co-Chief Executive Officer of BioTime. “We are honored to be working with two of the leading U.S. clinicians in ophthalmology, Dr. David S. Boyer and Dr. H. Richard McDonald. The sites are currently going through the set-up process, and we anticipate enrolling and treating U.S.-based patients by the end of the second quarter.”
David S. Boyer, M.D., is an ophthalmologist and senior partner with Retina-Vitreous Associates Medical Group in Los Angeles. He is a renowned clinician, surgeon and educator specializing in the treatment of diseases of the retina and vitreous. Dr. Boyer is one of the leading retinal clinical researchers in the country for new treatments in macular degeneration and diabetic macular edema. A widely-published author and avid lecturer, he lectures nationally and internationally on retinal research and the innovative approach to the treatment of retinal diseases.
H. Richard McDonald, M.D., is an ophthalmologist and senior partner at West Coast Retina Medical Group in San Francisco. He is the President-Elect of the Macula Society and a long time member of the Retina Society and American Society of Retinal Specialists. Dr. McDonald is a Section Editor of the Journal Retina, lectures nationally and internationally, and has written numerous papers, book chapters and editorials. He has received the Lifetime Achievement award from the American Academy of Ophthalmology.
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 trial is a Phase I/IIa dose escalation study 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. Data from the cohort were presented at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) in Rome, on December 2, 2016 and at the Angiogenesis meeting in Miami, Florida on February 11, 2017…..
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Source: Business Wire