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The administration of the implant in cohort 3 is being optimized for cell concentration and volume prior to Cohort 4. In cohort 4, the Company plans to treat patients in earlier stages of the disease that are likely be the target patient population for the therapy.
“Our team is enthusiastic about the early data showing a positive response from the implanted cells,” commented Dr. McDonald. “The DSMB’s approval is an important milestone. We look forward to enrolling our first patient in the trial as this is a debilitating disease."
“We are seeing encouraging signals of biological activity in the early
stages of the OpRegen clinical program and we look forward to the
continued progression of the trial,” commented
The Phase I/IIa clinical trial is evaluating the safety and efficacy of
implantation regimens of OpRegen in the advanced form of dry-AMD.
Dry-AMD is the leading cause of blindness in people over 60, and a
condition for which there is currently no FDA-approved therapy.
OpRegen has received Fast Track designation from the U.S. Food and Drug
The Company presented data from the Phase I/IIa clinical trial
of OpRegen at the
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
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.
BioTime common stock is traded on the NYSE MKT and TASE under the symbol
BTX. For more information, please visit www.biotimeinc.com or
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Certain statements contained in this release are “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Statements pertaining to future financial and/or
operating results, future growth in research, technology, clinical
development, and potential opportunities for
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