Data From BioTime’s OpRegen® Trial in Dry-AMD to be Presented at ARVO on May 8
March 15 2017 - 7:00AM
Business Wire
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:Title: 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 resultsDate/Time: May 8,
2017 from 3:45 PM to 5:30 PMPoster Number: 2320 -
B0274Session 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).
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 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.
About BioTime
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 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 the Company’s 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, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170315005403/en/
Investor Contact:EVC Group, Inc.Brian Moore,
310-770-0389bmoore@evcgroup.comorMedia Contact:Gotham
Communications, LLCBill Douglass,
646-504-0890bill@gothamcomm.com
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