-Data from patients in Cohort 1 and Cohort 2
to be presented-
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 Baltimore, Maryland.
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, respectively.
As previously announced, upcoming program milestones are
expected to include:
- Expansion of OpRegen® into the initial
U.S. clinical sites in the coming weeks,
- 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
dry-AMD.
About OpRegen®
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.
About BioTime
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 or connect with the company on Twitter,
LinkedIn, Facebook, YouTube, and Google+.
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, Inc. 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.
To receive ongoing BioTime corporate communications, please
click on the following link to join our email alert list:
http://news.biotimeinc.com.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170119005455/en/
Investor Contact:EVC Group, Inc.Matt Haines,
917-733-9297mhaines@evcgroup.comorMedia Contact:Gotham
Communications, LLCBill Douglass,
646-504-0890bill@gothamcomm.com
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