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 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
click on the following link to join our email alert list:
http://news.biotimeinc.com
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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