BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company developing new cellular therapies, announced today that updated results from a Phase I/IIa clinical study of its lead product candidate, OpRegen, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy, will be presented at the 2019 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2019), to be held April 28 through May 2, 2019 at the Vancouver Convention Centre in Vancouver, BC, Canada.
The abstract presentation, entitled, Phase I/IIa Clinical Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results, will be presented as part of the Advances in Retinal Gene Therapy and Stem Cells Session on May 2, 2019 between 10:15 AM and 12:00 PM EDT in Session Number 530 by Eyal Banin, MD, PhD, Professor of Ophthalmology, Director, Center for Retinal and Macular Degenerations, Department of Ophthalmology at Hadassah-Hebrew University Medical Center (presentation number 6402). The abstract will provide updated data from patient cohorts 1 through 3 of the study and new data from the ongoing patient cohort 4 in better vision patients.
In addition, BioTime will present preclinical results from its Vision Restoration Program, the Companys proprietary research program focused on developing technology that allows the generation of three-dimensional human retinal tissue derived from human pluripotent cells. BioTimes three-dimensional retinal tissue technology is being developed to potentially address a wide range of severe retinal degenerative conditions (e.g. retinitis pigmentosa and advanced forms of AMD) through a retinal tissue restoration strategy. In 2017, the Small Business Innovation Research program of the National Institutes of Health awarded BioTime a grant of up to $1.56 million to further develop this innovative, next generation vision restoration program.
- The poster presentation, entitled, Transplantation of human embryonic stem cell derived retinal tissue in the subretinal space of immunodeficient rats with retinal degeneration (RD), will be presented as part of the Animal Models for Visual Disease and Restoration Session on April 30, 2019 between 8:45am and 10:30am EDT in Session Number 332 by Igor Nasonkin, PhD, Principal Investigator, Director of Research & Development at BioTime, Inc. (Posterboard Number: 3109 – A0500).
- The poster presentation, entitled, Evaluation of selected Human Embryonic Stem Cell Lines for differentiation to three-dimensional retinal tissue (organoids) for cell therapies of retinal degenerative conditions, will be presented as part of the Stem Cells and Retinal Organoids: Disease Modeling Session on April 30, 2019 between 8:45am and 10:30am EDT in Session Number 323 by Ratnesh Singh, PhD, Senior Scientist at BioTime, Inc. (Posterboard Number: 2873 – A0044).
OpRegen is a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry AMD, the leading cause of adult blindness in the developed world. OpRegenconsists of a suspension of RPE cells delivered subretinally as an intraocular injection. RPE cells are essential components of the back lining of the retina and function to help nourish the retina including photoreceptors. OpRegen has been granted Fast Track designation from the U.S. Food and Drug Administration.
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About BioTime, Inc.
BioTime is a clinical-stage biotechnology company developing new cellular therapies for degenerative retinal diseases, neurological conditions associated with demyelination, and aiding the body in detecting and combating cancer. BioTimes programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform BioTime develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury, or administered as a means of helping the body mount an effective immune response to cancer. BioTimes clinical assets include (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, the leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. For more information, please visit www.biotimeinc.com.
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