BioTime, Inc. (NYSE MKT: BTX), a clinical-stage
biotechnology company developing and commercializing products
addressing degenerative diseases, today announced that an abstract
related to the Company’s retinal tissue implant has been accepted
for a paper presentation at the American Academy of Ophthalmology
(AAO) annual meeting being held in New Orleans, Louisiana, November
11-14.
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 Bascom Palmer Eye Institute.
“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 Adi Mohanty, co-Chief Executive
Officer. “This is a significant opportunity to broaden awareness
among clinicians about the significant progress of the OpRegen
program.”
The Company announced data from the Phase I/IIa clinical trial
of OpRegen at the Association for Research in Vision and
Ophthalmology (ARVO) annual meeting in May. The presentation
reported new clinical trial data with two patients that were
treated in cohort 2, where they received a dose of 200,000 cells.
Imaging analysis suggests the transplanted OpRegen cells remained
in place (engrafted) in an area of the scar that was completely
depleted of retinal pigment epithelium (RPE) because of the
advanced stages of the disease. Cell engraftment appears evident in
four of the five patients treated thus far. There was also possible
evidence of a biological response with some areas appearing to show
structural improvement (a thickening of the area of the neural
retina above the scar) without any signs of retinal edema, a fluid
build-up that can further compromise vision.
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
FDA.
About OpRegen®
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.
About BioTime
BioTime is a clinical-stage biotechnology company focused on
developing and commercializing products addressing degenerative
diseases. Our clinical programs are based on two platform
technologies: pluripotent cells and cell/drug delivery. The
foundation of our core therapeutic technology platform is
pluripotent cells that are capable of becoming any of the cell
types in the human body. The foundation of our cell delivery
platform is its HyStem® cell and drug delivery matrix technology.
The Company’s current clinical programs are targeting three primary
sectors, aesthetics, ophthalmology and cell/drug delivery. We also
have significant equity holdings in two publicly traded companies,
Asterias Biotherapeutics, Inc. (“Asterias”) and OncoCyte
Corporation (“OncoCyte”), which we founded and which, until
recently, were our majority-owned consolidated subsidiaries.
BioTime common stock is traded on the NYSE MKT and TASE under
the symbol BTX. For more information, please visit
www.biotimeinc.com or connect with the company on Twitter,
LinkedIn, Facebook, YouTube, and Google+.
To receive ongoing BioTime corporate communications, please
click on the following link to join our email alert list:
http://news.biotimeinc.com.
Forward-Looking Statements
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 BioTime, Inc. and its subsidiaries, along with
other statements about the future expectations, beliefs, goals,
plans, or prospects expressed by management constitute
forward-looking statements. Any statements that are not historical
fact (including, but not limited to statements that contain words
such as “will,” “believes,” “plans,” “anticipates,” “expects,”
“estimates” should also be considered to be forward-looking
statements. Forward-looking statements involve risks and
uncertainties, including, without limitation, risks inherent in the
development and/or commercialization of potential products,
uncertainty in the results of clinical trials or regulatory
approvals, need and ability to obtain future capital, and
maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the business of BioTime,
Inc. and its subsidiaries, particularly those mentioned in the
cautionary statements found in more detail in the “Risk Factors”
section of its Annual Reports on Form 10-K and Quarterly Reports on
Form 10-Q filed with the SEC (copies of which may be obtained at
www.sec.gov). Subsequent events and developments may cause these
forward-looking statements to change. BioTime specifically
disclaims any obligation or intention to update or revise these
forward-looking statements as a result of changed events or
circumstances that occur after the date of this release, except as
required by applicable law.
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version on businesswire.com: http://www.businesswire.com/news/home/20170719005222/en/
Investor Contact:EVC Group, Inc.Michael Polyviou,
646-445-4800mpolyviou@evcgroup.comorDoug Sherk,
646-445-4800dsherk@evcgroup.comorMedia Contact:JQA Partners,
Inc.Jules Abraham, 917-885-7378jabraham@jqapartners.com
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