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- IND filed for a Phase I/IIa dose escalation trial in patients with dry-AMD
- No approved therapy exists for dry-AMD, the leading cause of visual impairment in the aging population
- OpRegen® will be the first preparation of xeno-free RPE cells to be evaluated clinically for dry-AMD
The design of the proposed clinical trial, “Phase I/IIa Dose Escalation
Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal
Pigment Epithelium Cells Transplanted Subretinally in Patients with
Advanced Dry-Form Age-Related Macular Degeneration with Geographic
Atrophy,” is based on a pre-IND meeting with the
“The filing of this IND is the culmination of 12 years of research and
development starting at the
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is one of the major diseases of
aging and is the leading eye disease responsible for visual impairment
of older persons in the US,
Cell Cure's OpRegen® consists of RPE cells that are produced using a proprietary process that drives the differentiation of human embryonic stem cells into high purity RPE cells. OpRegen® is also “xeno-free," meaning that no animal products were used either in the derivation and expansion of the human embryonic stem cells or in the directed differentiation process. The avoidance of the use of animal products eliminates some safety concerns. OpRegen® is formulated as a suspension of RPE cells. Preclinical studies in mice have shown that following a single subretinal injection of OpRegen® as a suspension of cells, the cells can rapidly organize into their natural monolayer structure and survive throughout the lifetime of the animal. OpRegen® will be an “off-the-shelf” allogeneic product provided to retinal surgeons in a final formulation ready for transplantation. Unlike treatments that require multiple injections into the eye, such as currently-marketed products like Lucentis and Eylea for wet-AMD, it is expected that OpRegen® would be administered in a single procedure.
Asterias Biotherapeutics, Inc. is developing pluripotent stem-cell based therapies in neurology and oncology, including AST-OPC1 oligodendrocyte progenitor cells in spinal cord injury, multiple sclerosis and stroke, and AST-VAC2, an allogeneic dendritic cell-based cancer vaccine. Asterias trades publicly under the symbol ASTY.
BioTime Asia, Ltd., a
Hong Kongcompany, may offer and sell products for research use for BioTime’s ESI BIO Division.
Cure Neurosciences Ltd. is an
Israel-based biotechnology company focused on developing stem cell-based therapies for retinal and neurological disorders, including the development of retinal pigment epithelial cells for the treatment of macular degeneration, and treatments for multiple sclerosis.
ESI BIOis the research and product marketing division of BioTime, providing stem cell researchers with products and technologies to enable them to translate their work into the clinic, including PureStem® progenitors and HyStem® hydrogels.
- LifeMap Sciences, Inc. markets, sells, and distributes GeneCards®, the leading human gene database, as part of an integrated database suite that also includes the LifeMap Discovery® database of embryonic development, stem cell research, and regenerative medicine, and MalaCards, the human disease database.
- LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences focused on developing mobile health (mHealth) products.
- OncoCyte Corporation is developing products and technologies to diagnose and treat cancer, including PanC-Dx™, with four clinical studies currently underway.
- OrthoCyte Corporation is developing therapies to treat orthopedic disorders, diseases and injuries.
- ReCyte Therapeutics, Inc. is developing therapies to treat a variety of cardiovascular and related ischemic disorders, as well as products for research using cell reprogramming technology.
Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and
potential opportunities for
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FDAfor OpRegen, for Dry-AMD $BTX http://bit.ly/ULNXY
Judith Segall, 510-521-3390 ext. 301