BioTime Announces Publication of Positive Preclinical Results Utilizing Proprietary HyStem® Platform in Ischemic Stroke
December 04 2018 - 8:00AM
Business Wire
Data Suggest That Targeted Intracerebral
Delivery of Brain-Derived Neurotrophic Factor Utilizing HyStem®
Delivery Platform May Mitigate Ischemic Brain Injury and Restore
Functional Benefits
BioTime, Inc. (NYSE American: BTX), a clinical-stage
biotechnology company focused on degenerative diseases, today
announced the publication of positive preclinical results which
demonstrate that targeted intracerebral delivery of brain-derived
neurotrophic factor utilizing HyStem®, BioTime’s proprietary
hydrogel delivery platform technology, may mitigate ischemic brain
injury and restore functional benefits by reducing
neuroinflammation. The article entitled, “Intracerebral Delivery of
Brain-Derived Neurotrophic Factor Using HyStem®-C Hydrogel Implants
Improves Functional Recovery and Reduces Neuroinflammation in a Rat
Model of Ischemic Stroke,” was published in the International
Journal of Molecular Sciences and is authored by clinicians at the
Stanford University School of Medicine, Department of
Neurosurgery.
“Results from this study, designed to simulate the clinical
needs of human stroke, underscore the ability of our proprietary
HyStem® delivery technology to target therapy dosing to a specific
anatomical site such as to the ischemic core, and minimize
dissipation to surrounding tissues,” stated Francois Binette, SVP
and Global Head of Product Development at BioTime. “Brain-derived
neurotrophic factor (BDNF) is responsible for regulating neural
stem cell differentiation and survival, synapse development, and
plays a key role in the neuro-reparative processes that mediate
cortical connectivity and promote post-stroke recovery. In this
model, utilizing our HyStem® delivery platform, BDNF was shown over
a three-week period to be continuously released to the surrounding
tissue, which could allow for better long-term tissue and
functional effects to occur compared to a regular bolus
injection.”
Ischemic stroke is a leading cause of death and disability, and
the ischemic brain remains a difficult to reach anatomical target
because of the blood-brain barrier which limits availability of
systemically administered drugs. In order to reach therapeutic
levels for neural repair and functional recovery, many stroke
therapies would have to be administered at very high systemic doses
because of the blood-brain barrier, and therefore increasing risks
of systemic or off-target side effects. Implantable drug depots are
being explored as a novel approach for the delivery of treatments
directly to the brain. BioTime’s HyStem® technology features a
unique, biocompatible hydrogel designed to provide a
controlled-release drug depot and enable the effective delivery of
small and large biologic molecules.
In the published study, clinicians examined the effects of BDNF,
delivered via an extended release HyStem®-C hydrogel, on
sensorimotor function, infarct volume, and neuroinflammation,
following permanent distal middle cerebral artery occlusion (dMCAo)
in rats. Improved sensorimotor function was observed in rats
treated with hydrogel + BDNF(HIGH), particularly six to eight weeks
following treatment implantation. Infarct volume was reduced in
rats treated with hydrogel + BDNF(HIGH) as were levels of
microglial, phagocyte, and astrocyte marker immunoexpression in the
corpus striatum. These data suggest that targeted intracerebral
delivery of BDNF using hydrogels may mitigate ischemic brain injury
and restore functional deficits by reducing neuroinflammation.
About Stanford University School of Medicine, Department of
Neurosurgery
The Department of Neurosurgery at Stanford University School of
Medicine is a world leader in the fast-paced environment of
innovative research translation. The rich intellectual environment
at Stanford, paired with accessibility to the most advanced
technology, is unmatched and ensures the rapid translation of
pioneering laboratory research into life-saving clinical therapies
for our patients. The Department of Neurosurgery supports over 30
active labs investigating everything from brain injury,
deep brain stimulation, brain tumors, epilepsy, pathophysiology and
treatment of acute stroke, to the effects of stress and aging on
the nervous system. More information can be found online or via
Twitter at @TopNeuroDocs.
About HyStem®
HyStem® is BioTime’s cell and drug delivery platform. HyStem®
technology includes a family of unique, biocompatible hydrogels
designed to effectively deliver cells or bioactive compositions for
therapeutic benefit. HyStem® was designed to enable the effective
transfer, engraftment and metabolic support for cells. The flexible
chemistry of the HyStem® also allows for hydrogel optimization in
the delivery of drugs and therapeutics. BioTime is actively
pursuing local delivery aspects of this platform technology.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company focused
on the development and commercialization of novel therapies for the
treatment of degenerative diseases. BioTime’s pipeline is based on
two platform technologies which encompass cell replacement and
cell/drug delivery. BioTime’s lead cell replacement product
candidate is OpRegen®, a retinal pigment epithelium transplant
therapy in Phase 2 development for the treatment of dry age-related
macular degeneration, the leading cause of blindness in the
developed world. BioTime’s lead cell delivery clinical program is
Renevia®, an investigational medical device being developed as an
alternative for whole adipose tissue transfer procedures.
BioTime common stock is traded on the NYSE American and TASE
under the symbol BTX. For more information, please
visit www.biotime.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.biotime.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. 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 forward-looking
statements. Forward-looking statements involve risks and
uncertainties. 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 BioTime’s Annual
Reports on Form 10-K and Quarterly Reports on Form 10-Q (copies of
which may be obtained at www.sec.gov). Subsequent events and
developments may cause these forward-looking statements to change.
BioTime 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.
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BioTime Inc. IRIoana C. Hone(ir@biotimeinc.com)(510)
871-4188
Solebury Trout IRGitanjali Jain
Ogawa(Gogawa@troutgroup.com)(646) 378-2949
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