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.
“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.
“I am excited about the potential of BioTime’s OpRegen® for the treatment of dry-AMD, the leading cause of blindness in the elderly,” commented Dr. Boyer. “In my practice I routinely encounter patients who are suffering from various stages of dry-AMD, a debilitating condition for which no currently approved therapy exists. I would like nothing more than to be able to offer my patients an effective treatment for it, especially one that may be able to preserve and possibly even help restore function. Data on the first patient cohort and progress to date is very encouraging, and I am eagerly anticipating treating patients.”
“Dry-AMD is the only major eye disease for which no treatment is available and it affects a significantly higher number of people than the wet form of AMD. I look forward to the initiation of this important clinical trial to see if this treatment can arrest and potentially reverse the course of this disease, which inevitably leads to blindness,” said Dr. McDonald.
About Dry Age-Related Macular Degeneration (Dry-AMD)
Macular degeneration affects approximately 11 million people in the U.S. and is the leading cause of blindness in people over the age of 60. Approximately 90 percent of these patients suffer from the dry form, for which there are no FDA-approved therapies. In dry-AMD, there is a loss or dysfunction of the layer of retinal pigment epithelial (RPE) cells generally in the region of the eye called the macula, which is the part of the retina responsible for sharp, central vision that is important for facial recognition, reading and driving. These RPE cells support the light detecting photoreceptor cells that are so critical to vision. When we look at something, the photoreceptors (rods and cones) detect the light and send the information to the brain allowing us to perceive our surroundings. The age-dependent loss of the RPE cells therefore leads to degeneration of nearby photoreceptors and this can lead to severe vision loss or even legal blindness. Generally, the damage caused by the “dry” form is not as severe or rapid as that of the “wet” form. However, in the advanced stage of dry macular degeneration widespread loss of RPE and photoreceptors in the macular area, called geographic atrophy, leads to severe vision loss. While therapeutics are available to treat the wet form of AMD, there are currently no FDA-approved therapies for dry-AMD.
About OpRegen®
OpRegen® for the treatment of the dry form of age-related macular degeneration (AMD), consists of a suspension of Retinal Pigment Epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. A proprietary process that drives the differentiation of human pluripotent stem cells is used to generate high purity OpRegen® RPE cells. OpRegen® RPE cells are also “xeno-free," meaning that no animal products are used either at any point in the derivation and production process. The avoidance of the use of animal products eliminates some potential safety concerns. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen®, the cells can rapidly organize into its natural monolayer structure in the subretinal space and survive throughout the lifetime of the animal. OpRegen® is designed to be an “off-the-shelf” allogeneic (non-patient specific) product. Unlike treatments that require multiple, frequent injections into the eye, it is expected that OpRegen® would be administered in a single procedure. OpRegen® was granted Fast Track designation from FDA which allows more frequent interactions with the agency, and eligibility for accelerated approval and priority review. OpRegen® is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime, Inc.
About BioTime
BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what the company believes to be the world’s premier collection of pluripotent cell assets. The foundation of BioTime’s core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products.
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