Additional Data From BioTime’s OpRegen® Clinical Trial in Dry-AMD to be Presented at ARVO 2017
-Data from patients in Cohort 1 and Cohort 2 to be presented-
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 19, 2017--
BioTime, Inc. (NYSE MKT:BTX), a clinical stage biotechnology company
with a focus on pluripotent stem cell technologies, and its subsidiary,
Cell Cure Neurosciences, Ltd., today announced that an abstract
evaluating OpRegen® in patients with advanced dry Age-Related Macular
Degeneration (dry-AMD) based on the ongoing Phase I/IIa clinical trial
will be presented at the Association for Research in Vision and
Opthalmology (ARVO) meeting taking place from May 7-11, 2017, in
The abstract, titled “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 results”, will be presented by Professor Eyal Banin,
M.D., Ph.D., Director of the Center for Retinal and Macular
Degenerations at Hadassah Medical Center, Jerusalem, Israel. Professor
Banin will be presenting complete data on patients in cohort 1,
including follow-up of up to one year, and the most up-to-date data from
patients in cohort 2 of the clinical trial. Patients in cohort 1 and
cohort 2 received 50,000 and 200,000 OpRegen® cells in suspension,
As previously announced, upcoming program milestones are expected to
Expansion of OpRegen® into the initial U.S. clinical sites in the
Further data from cohort 2 in the first half of this year,
Beginning enrollment of cohort 3 of this trial in the coming months,
Completing enrollment of cohort 3 and 4 this year and
Reporting data from cohort 3 of the trial this year.
About Dry Age-Related Macular Degeneration (Dry–AMD)
Macular degeneration affects approximately 11 million people in the U.S.
It 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
people look at something, the photoreceptors (rods and cones) detect the
light and send the information to their brain allowing them to perceive
their surroundings. The age-dependent loss of RPE cells leads to
degeneration of nearby photoreceptors, which 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 impairment. While therapeutics are available to treat
the wet form of AMD, there are currently no FDA-approved therapies for
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 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 the 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 the OpRegen® Clinical Trial
The Phase I/IIa open label safety and efficacy clinical trial is
designed to evaluate three different dose regimens of OpRegen® in four
cohorts. Cohort 1 includes three patients each receiving 50,000 cells,
cohort 2 includes three patients each receiving 200,000 cells, upon DSMB
approval cohort 3 will include three patients each receiving 500,000
cells, and upon DSMB approval cohort 4 will include six patients each
receiving 500,000 cells.
Following transplantation, the patients will be followed for 12 months
at specified intervals in order to evaluate the safety and tolerability
of the product. Following the initial 12 month period, patients will
continue to be monitored at longer intervals.
A secondary objective of the clinical trial will be to examine the
ability of transplanted OpRegen® to engraft, survive, and modulate
disease progression in the patients. In addition to thorough
characterization of visual function, a battery of vision tests will be
used to quantify improvements in reducing the progression of the disease.
BioTime, Inc. is a clinical-stage biotechnology company focused on
developing and commercializing products addressing degenerative
diseases. The foundation of BioTime’s core therapeutic technology
platform is pluripotent cells. Pluripotent cells 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
BTX. For more information, please visit www.biotimeinc.com
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