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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
“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
The Company announced data from the Phase I/IIa clinical trial of
OpRegen at the
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
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.
To receive ongoing
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
EVC Group, Inc.
Michael Polyviou, 646-445-4800
Doug Sherk, 646-445-4800
JQA Partners, Inc.
Jules Abraham, 917-885-7378