Data to be Presented at Association for
Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting
BioTime, Inc. (NYSE MKT: BTX) and its subsidiary Cell Cure
Neurosciences Ltd. (Cell Cure) today announced that preclinical
data demonstrating that Cell Cure’s product candidate, OpRegen®,
preserved vision and retinal structure when transplanted into the
leading animal model of retinal disease, will be presented at the
Association for Research in Vision and Ophthalmology (ARVO) 2015
Annual Meeting taking place May 3-7, 2015, in Denver, Colorado.
OpRegen® consists of animal product-free retinal pigment epithelial
(RPE) cells with high purity and potency.
The preclinical study was conducted by a scientific team led by
Trevor J. McGill, Ph.D., Research Assistant Professor at the Casey
Eye Institute, Oregon Health and Science University. The abstract
accepted for paper presentation is titled, “Long Term Efficacy of
Xeno-free hESC-derived RPE Cells Following Transplantation into
Royal College of Surgeons Rats.” The data that will be presented by
Michael D. Andrews of the Casey Eye Institute, Oregon Health and
Science University, and lead study investigator, during session
202, titled, “Retinal degeneration and disease: experimental
models,” is scheduled for Monday, May 4, 2015 from 9:00 AM to 9:15
AM Mountain Time Zone. The abstract number is 1275. The
presentation abstract is available online at the ARVO website at
http://www.arvo.org/Online_Planner/.
Cell Cure has received regulatory clearance from the U.S. Food
and Drug Administration (FDA) and the Israeli Ministry of Health to
initiate a Phase I/IIa dose escalation safety and efficacy clinical
study of OpRegen® for geographic atrophy (GA), the severe stage of
the dry form of age-related macular degeneration (dry-AMD). Patient
enrollment has started at Hadassah University Medical Center in
Jerusalem, Israel. The trial consists of four cohorts and will
evaluate three different dose regimens. Details of the trial are
available at https://clinicaltrials.gov/. Cell Cure expects to
report interim data from the cohorts in the coming months.
While treatment options exist for the wet form of AMD, which
represents about 10% of the disease prevalence, there is currently
no FDA-approved therapy for the dry form that occurs in
approximately 90% of those afflicted with AMD. Cell Cure intends to
transplant OpRegen® as a single dose into the subretinal space of
patients’ eyes in order to test the safety and efficacy of the
product in this leading cause of blindness.
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is one of the major
diseases of aging and is the leading eye disease responsible for
visual impairment of older persons in the US, Europe and Australia.
AMD affects the macula, which is the part of the retina responsible
for sharp, central vision that is important for facial recognition,
reading and driving. There are two forms of AMD. The dry form
(dry-AMD) advances slowly and painlessly but may progress to
geographic atrophy (GA) in which RPE cells and photoreceptors
degenerate and are lost. Once the atrophy involves the fovea (the
center of the macula), patients lose their central vision and may
develop legal blindness. There are about 1.6 million new cases of
dry-AMD in the US annually, and as yet there is no effective
treatment for this condition. About 10% of patients with dry-AMD
develop wet (or neovascular) AMD, the second main form of this
disease, which usually manifests acutely and can lead to severe
visual loss in a matter of weeks. Wet-AMD can be treated with
currently-marketed VEGF inhibitors such as Lucentis or Eylea.
However, such products typically require frequent repeated
injections in the eye, and patients often continue to suffer from
continued progression of the underlying dry-AMD disease process.
Current estimated annual sales of VEGF inhibitors for the treatment
of the wet form of AMD are estimated to be about $8 billion
worldwide. The root cause of the larger problem of AMD is believed
to be the dysfunction of RPE cells. One of the most exciting
therapeutic approaches to dry-AMD is the transplantation of
healthy, young RPE cells to support and replace the patient’s old
degenerating RPE cells, which may prevent progression of the
atrophy as well as the development of wet-AMD. Pluripotent stem
cells, such as human embryonic stem cells (hESCs), can provide an
unlimited source for the derivation of such healthy RPE cells for
transplantation.
About OpRegen®
Cell Cure's OpRegen® consists of RPE cells that are produced
using a proprietary process that drives the differentiation of
human embryonic stem cells into high purity RPE cells. OpRegen® is
also “xeno-free," meaning that no animal products were used either
in the derivation and expansion of the human embryonic stem cells
or in the directed differentiation process. The avoidance of the
use of animal products eliminates some safety concerns. OpRegen® is
formulated as a suspension of RPE cells. Preclinical studies in
mice have shown that following a single subretinal injection of
OpRegen® as a suspension of cells, the cells can rapidly organize
into their natural monolayer structure and survive throughout the
lifetime of the animal. OpRegen® will be an “off-the-shelf”
allogeneic product. Unlike treatments that require multiple,
frequent injections into the eye, it is expected that OpRegen®
would be administered in a single procedure.
About Cell Cure Neurosciences Ltd.
Established in 2005, Cell Cure is located in Jerusalem, Israel
on the campus of Hadassah Medical Center. Cell Cure's mission is to
become a leading supplier of human cell-based therapies for the
treatment of retinal and neural degenerative diseases. Its
technology platform is based on the manufacture of diverse cell
products sourced from clinical-grade (GMP-compatible) human
embryonic stem cells. Its current focus is the development of
retinal pigment epithelial (RPE) cells for the treatment of
age-related macular degeneration. Cell Cure's major shareholders
include BioTime, Inc. (NYSE MKT: BTX), HBL Hadasit Bio-Holdings
Ltd., Teva Pharmaceuticals Industries Ltd., and Asterias
Biotherapeutics, Inc. Additional information about Cell Cure can be
found on the web at www.cellcureneurosciences.com.
About BioTime
BioTime, Inc., a pioneer in regenerative medicine, is a
clinical-stage biotechnology company. BioTime and its subsidiaries
are leveraging their industry-leading experience in pluripotent
stem cell technology and a broad intellectual property portfolio to
facilitate the development and use of cell-based therapies and gene
marker-based molecular diagnostics for major diseases and
degenerative conditions for which there presently are no cures. The
lead clinical programs of BioTime and its subsidiaries include:
OpRegen®, currently in a Phase I/IIa trial for the treatment of the
dry form of age-related macular degeneration; AST-OPC1, currently
in a Phase I/IIa trial for spinal cord injuries; Renevia™,
currently in a pivotal trial in Europe as an injectable matrix for
the engraftment of transplanted cells to treat HIV-related
lipoatrophy; and PanC-Dx™ cancer diagnostics, which are completing
initial clinical studies for bladder, breast, and lung cancer.
AST-VAC2, a cancer vaccine, is in the pre-clinical trial stage.
BioTime’s subsidiaries include: publicly-traded Asterias
Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem
cell-based therapies in neurology and oncology, including AST-OPC1
and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem
cell-based therapies for retinal and neurological disorders,
including OpRegen®; OncoCyte Corporation, developing PanC-Dx™
cancer diagnostics; LifeMap Sciences, Inc., developing and
marketing an integrated on-line database resource for biomedical
and stem cell research; LifeMap Solutions, Inc., a subsidiary of
LifeMap Sciences, developing mobile health (mHealth) products; ES
Cell International Pte Ltd, which has developed cGMP compliant
human embryonic stem cell lines that are being marketed by BioTime
for research purposes under the ESI BIO branding program; OrthoCyte
Corporation, developing therapies to treat orthopedic disorders,
diseases and injuries; and ReCyte Therapeutics, Inc., developing
therapies to treat a variety of cardiovascular and related ischemic
disorders.
BioTime common stock is traded on the NYSE MKT 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
Statements pertaining to future financial and/or operating
results, future growth in research, technology, clinical
development, and potential opportunities for BioTime 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 and
its subsidiaries, particularly those mentioned in the cautionary
statements found in BioTime's Securities and Exchange Commission
filings. BioTime disclaims any intent or obligation to update these
forward-looking statements.
To receive ongoing BioTime corporate communications, please
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BioTime, Inc.Judith Segall, 510-521-3390, ext
301jsegall@biotimemail.comorInvestor Contact:EVC Group, Inc.Gregory
Gin, 862-236-0673ggin@evcgroup.comMichael Polyviou,
212-850-6020mpolyviou@evcgroup.comDoug Sherk,
415-652-9100dsherk@evcgroup.com
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