Data From BioTime’s OpRegen® Trial in Dry-AMD to be Presented at ARVO on May 8
ALAMEDA, Calif.--(BUSINESS WIRE)--Mar. 15, 2017--
BioTime, Inc. (NYSE MKT:BTX), a clinical-stage biotechnology company
developing and commercializing products addressing degenerative
diseases, today announced that a poster presentation based on data from
its Phase I/IIa clinical trial of OpRegen® in the
advanced form of dry age-related macular degeneration (dry-AMD) will be
presented at the Annual
Meeting of the Association for Research in Vision and Ophthalmology
(ARVO) on Monday, May 8, 2017, in Baltimore, Maryland.
Details of the Poster Presentation are as follows:
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
Date/Time: May 8, 2017 from 3:45 PM to 5:30 PM
Number: 2320 - B0274
Session Title: AMD translational
studies and choroidal neovascularization
OpRegen®, is now being evaluated in a dose-escalating Phase
I/IIa clinical study in patients with advanced dry-AMD accompanied by
geographic atrophy. OpRegen® has received Fast Track
designation from the FDA for treatment of the advanced form of dry-AMD.
Details of the trial and about a patient’s eligibility are available at https://clinicaltrials.gov/
with the following Identifier: NCT02286089 (dry-AMD).
OpRegen® 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. 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 either 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.
BioTime, Inc. is a clinical-stage biotechnology company focused on
developing and commercializing novel therapies developed from what the
company believes to be the world’s premier collection of pluripotent
cell assets. The foundation of BioTime’s core therapeutic technology
platform is pluripotent cells that are capable of becoming any of the
cell types in the human body. Pluripotent cells have potential
application in many areas of medicine with large unmet patient needs,
including various age-related degenerative diseases and degenerative
conditions for which there presently are no cures. Unlike
pharmaceuticals that require a molecular target, therapeutic strategies
based on the use of pluripotent cells are generally aimed at
regenerating or replacing affected cells and tissues, and therefore may
have broader applicability than pharmaceutical products.
BioTime common stock is traded on the NYSE MKT and TASE under the symbol
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subsidiaries, particularly those mentioned in the cautionary statements
found in more detail in the “Risk Factors” section of its Annual Reports
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Source: BioTime, Inc.
EVC Group, Inc.
Gotham Communications, LLC