#OpRegen by Biotime $BTX:
The Company announced data from the Phase I/IIa 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.
PR:
Data From BioTime's Phase I/IIa OpRegen® Trial to be Presented at the 2017 American Academy of Ophthalmology (AAO) Annual Meeting
Date(s): 19-Jul-2017 7:00 AM
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ALAMEDA, Calif.--(BUSINESS WIRE)--Jul. 19, 2017-- BioTime, Inc. (NYSE MKT: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today 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, Louisiana, 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 Dr. 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," commented Adi Mohanty, co-Chief Executive Officer. "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 I/IIa 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 I/IIa 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.
About OpRegen®
OpRegen®, which is being studied 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. RPE cells are essential components of the back lining of the retina, and function to help nourish the retina including photoreceptors. 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 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 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.
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