BioTime Announces Publication of Positive Preclinical Results Utilizing Proprietary HyStem Platform in Ischemic Stroke

Business Wire 4-Dec-2018 8:00 AM

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: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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