BioTime, Inc. (NYSE MKT:BTX) today announced that the clinical-grade
human Embryonic Stem (hES) cell lines from BioTime’s wholly-owned
subsidiary ES Cell International Pte Ltd (ESI, Singapore) will be used
by UC Irvine scientist Dr. Leslie Thompson to continue her promising
research in the use of stem cells to treat Huntington’s disease under a
$5 million grant from the California Institute for Regenerative Medicine
(CIRM). The CIRM grant will further support a collaboration between ESI
and UC Davis’s good-manufacturing-practice (GMP) laboratory for the
creation of the GMP grade cells needed in Dr. Thompson’s preclinical and
potentially subsequent clinical studies.
This collaboration is an example of BioTime’s strategy to leverage
collaborations and potentially generate future revenues by placing its
hES cells in a wide array of medical applications that BioTime could not
otherwise address with its own resources. ESI provides its hES cells as
both inexpensive research-grade cells through its ESI BIO division and
as GMP-compliant clinical grade cells for translation into clinical
applications, allowing researchers to conduct research with hES cells
that can also be used in the clinic.
According to Dr. Thompson, Professor, Departments of Psychiatry and
Human Behavior and Neurobiology and Behavior at the Sue and Bill Gross
Stem Cell Center, “Huntington’s disease is a devastating genetic
neurodegenerative disease that strikes individuals in the prime of life
and can be passed on for generations to come. There is no treatment that
changes the onset or course of the disease. The funding from CIRM for
this preclinical development grant will allow further preclinical
evaluation of a lead stem cell based treatment candidate, neural stem
cells derived from BioTime’s ESI-017 stem cells, in consultation with
the FDA. These cells have demonstrable protective effects following
transplantation in a mouse model of Huntington’s disease.”
Gerhard Bauer, Associate Professor, Director of the GMP Laboratory at UC
Davis says, “For the funded project, GMP grade hES cells will be
manufactured at the UC Davis GMP facility and differentiated into GMP
grade neuronal stem cells (NSCs) which are slated for a human clinical
application for the treatment of Huntington's disease. In previous
preclinical runs it was found that the particular hES line, ESI-017,
performed very well in pluripotent cell expansion and studies, and
reliably formed robust NSCs after differentiation. In addition, a novel
closed system hollow fiber bioreactor will also be used for larger scale
hES and NSC expansion. This is the first time that GMP grade pluripotent
stem cells will be applied for the treatment of Huntington's disease.”
Jeffrey Janus, ESI’s CEO commented, “It is reported that approximately
30,000 people in the U.S. have Huntington's disease while another
150,000 have a 50% chance of developing the disease. Because of the
protracted and debilitating course of the illness, and the current lack
of a cure, Huntington's disease is said to cost the U.S. about $2.5
billion annually. We are pleased and excited to be a part of this
important work by Dr. Thompson and her team at UC Irvine and UCLA and by
Dr. Bauer and his GMP cell manufacturing operation at UC Davis. This is
further evidence that CIRM funding and private investment in stem cell
science can work together to accelerate the translation of stem cell
technology to clinical application.”
Users of BioTime’s hES cells may need to obtain a license or other
permission from Wisconsin Alumni Research Foundation or other third
parties to conduct research, perform clinical trials, or to make or sell
any products based on the ESI hES cells.
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
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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.
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Copyright Business Wire 2015