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- This is the 10th year in receipt of an Israeli Government grant in support of Cell Cure
OpRegen® is currently in a Phase I/IIa dose-escalation clinical study evaluating the safety and efficacy of OpRegen® for geographic atrophy (GA), the severe stage of the dry form of age-related macular degeneration (dry-AMD). Dry-AMD is a leading cause of blindness in people over age 60, for which there is no currently approved therapy.
“We are proud to be one of Israel’s innovative life science companies,
and we want to thank the
The IIA has to date provided grants of approximately
About Dry Age-Related Macular Degeneration (Dry–AMD)
Dry-AMD is the most common type of macular degeneration and affects
approximately 90% of people with the disorder. 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 blindness. Generally, the damage
caused by the “dry” form is not as severe or rapid as that of the “wet”
form. However, over time, it can cause profound vision loss. The more
advanced stage of dry macular degeneration is called geographic atrophy.
While there are therapeutics available to treat the wet form of AMD,
there are currently no
OpRegen® consists of retinal pigment epithelial (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 its natural monolayer structure 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.
In addition to the development of therapeutics, BioTime’s research and other activities have resulted, over time, in the creation of other subsidiaries that address other non-therapeutic market opportunities such as cancer diagnostics, drug development and cell research products, and mobile health software applications.
Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and
potential opportunities for
To receive ongoing
Dan L. Lawrence, 510-775-0510
EVC Group, Inc.
Michael Polyviou, 646-445-4800
Gotham Communications, LLC
Bill Douglass, 646-504-0890