BioTime, Inc. (NYSE MKT:BTX) today announced that it has entered into a
collaboration with Susan Thibeault, Ph.D., of the University of
Wisconsin and Marc Remacle, M.D. of Louvain University to evaluate
BioTime’s proprietary HyStem®-based hydrogel
for the treatment of vocal fold scarring. Preclinical studies published
by Dr. Thibeault and her colleagues have demonstrated that localized
delivery of HyStem® into injured vocal folds
resulted in a significant improvement in function. Under a sponsored
research agreement, Dr. Thibeault’s laboratory will evaluate HyStem®-based
hydrogels to identify formulations with optimum properties for reducing
scarring. Upon completion of these preclinical studies, an
investigator-initiated clinical trial in patients with vocal fold
scarring due to disease or prior surgical interventions is planned,
under the direction of Dr. Remacle, at the Cliniques Universitaires UCL
Mont-Godinne in Belgium, subject to institutional and regulatory
approval.
Background
Scarring of the vocal folds is the most common cause of undesired
changes in the voice (dysphonia) following injury, disease, or surgical
procedures. Current treatments are limited to microsurgical treatments
including scar lysis/excision, medialization laryngoplasty, or
engraftment of tissue flaps/grafts. Since the region of the vocal fold
affected by scarring is rich in hyaluronic acid, nonclinical studies of HyStem®-based
hydrogels have been performed which indicate that localized injection of
a HyStem® hydrogel during surgical release of
the adhesions provides an environment for improved tissue
viscoelasticity vital for vocal fold function. Because vocal fold
scarring remains one of the most challenging problems for
otolaryngologists using the available technology, continued successful
preclinical studies could lead to investigator-initiated clinical
investigations, and efforts for regulatory approval for this indication.
“If products could be developed that would improve vocal fold healing
with decreased scarring, it could have widespread clinical application
for improved patient outcomes,” said Dr. Remacle, at the Cliniques
Universitaires UCL Mont-Godinne in Belgium.
“The expanded application of HyStem® hydrogels
in the field of vocal fold disorders, is just one example of the breadth
of potential applications of the technology,” said Dr. William Tew,
BioTime’s Chief Commercial Officer. “Our numerous academic
collaborations play an important role in advancing these novel
applications in medicine. For example, we are seeing numerous scientific
publications utilizing HyStem® technology
in stem cell transplantation in the central nervous system, heart,
liver, skin, orthopedic, and other tissues. We plan additional
collaborations to further expand the breadth of uses of HyStem®
technology as part of our strategy to aggressively commercialize
this platform.”
About HyStem®
BioTime’s HyStem® family of hydrogels are
unique biomaterials that are designed as matrices and scaffolds in
medical device, tissue engineering, and regenerative medicine
applications. HyStem® hydrogels are distributed
and sold worldwide by BioTime and its distributors for pre-clinical
research. Renevia™ is an injectable HyStem®
hydrogel, for which clinical studies in Europe are scheduled for the
purpose of evaluating Renevia™ as a delivery matrix for
autologous adipose cells to treat the facial lipoatrophy associated with
HIV. Premvia™ is a recently FDA-cleared medical device indicated
for the management of wounds. Clinical grade hydrogels are also
available to support translational research and investigator initiated
clinical studies. BioTime’s HyStem® technology
is covered by two issued US patents with applications pending in the EU,
Canada, Japan, and Australia.
About BioTime
BioTime is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime’s focus is on pluripotent stem cell technology based on
human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”)
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of proprietary PureStem®
progenitors, HyStem®
hydrogels, culture media, and differentiation kits. BioTime is
developing Renevia™ (a HyStem® product) as a
biocompatible, implantable hyaluronan and collagen-based matrix for cell
delivery in human clinical applications, and is planning to initiate a
pivotal clinical trial around Renevia™, in 2014. The HyStem®-based
product PremviaTM is cleared the FDA in the US
for use in wound management. In addition, BioTime has developed Hextend®,
a blood plasma volume expander for use in surgery, emergency trauma
treatment and other applications. Hextend® is
manufactured and distributed in the U.S. by Hospira, Inc. and in South
Korea by CJ HealthCare Corporation, under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
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Asterias
Biotherapeutics, Inc. is developing pluripotent stem-cell
based therapies in neurology and oncology, including AST-OPC1
oligodendrocyte progenitor cells in spinal cord injury, multiple
sclerosis and stroke, and AST-VAC2, an allogeneic dendritic cell-based
cancer vaccine. Asterias Series A common stock is traded under the
symbol ASTY.
-
BioTime Asia, Ltd., a Hong Kong company, may offer and sell
products for research use for BioTime’s ESI BIO Division.
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Cell
Cure Neurosciences Ltd. is an Israel-based biotechnology
company focused on developing stem cell-based therapies for retinal
and neurological disorders, including the development of retinal
pigment epithelial cells for the treatment of macular degeneration,
and treatments for multiple sclerosis.
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ESI
BIO is the research and product marketing division of BioTime,
providing stem cell researchers with products and technologies to
enable them to translate their work into the clinic, including PureStem®
progenitors and HyStem® hydrogels.
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LifeMap
Sciences, Inc. markets, sells, and distributes GeneCards®,
the leading human gene database, as part of an integrated database
suite that also includes the LifeMap
Discovery® database of embryonic development, stem
cell research, and regenerative medicine, and MalaCards,
the human disease database.
-
LifeMap
Solutions, Inc. is a subsidiary of LifeMap Sciences focused on
developing mobile health (mHealth) products.
-
OncoCyte
Corporation is developing products and technologies to diagnose and
treat cancer, including PanC-Dx™, with three clinical trials
currently underway.
-
OrthoCyte
Corporation is developing therapies to treat orthopedic disorders,
diseases and injuries.
-
ReCyte
Therapeutics, Inc. is developing therapies to treat a variety
of cardiovascular and related ischemic disorders, as well as products
for research using cell reprogramming technology.
BioTime stock is traded on the NYSE Market exchange, ticker 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 2014