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NEW YORK, April 30, 2019 (GLOBE NEWSWIRE) -- Brainstorm-Cell Therapeutics Inc., (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative disease, today announced that it has expanded its proprietary cellular technology platform to include NurOwn®-derived exosomes for potential development across a broad range of CNS (Central Nervous System) disorders.
Exosomes are nano-sized (30–120 nm), cell-derived vesicles that exhibit remarkable stability and may provide enhanced cell-to-cell delivery of bio-active molecules across the blood brain barrier into difficult to reach regions of the brain. Exosomal cargo provides important regulatory functions for many cell processes, including immunomodulation and neuroprotection.
“BrainStorm is leveraging cutting edge science and technology to continually explore and advance breakthrough scientific solutions,” said Revital Aricha PhD, BrainStorm’s VP R&D. She added, “We are actively developing our proprietary exosome technology as an ideal nano-carrier to effectively deliver bio-active molecules to the brain in a non-invasive manner, and leverage their exceptional biological properties, simplified long-term storage and transport which may facilitate repeat dosing as a potential allogeneic product in chronic neurodegenerative disease.”
“BrainStorm is committed to the development of highly innovative therapies for devastating neurodegenerative diseases,” said Chaim Lebovits, BrainStorm’s CEO. “We believe that exosomes have significant therapeutic potential in neurodegenerative disease through their unique biological characteristics, customizable cargo, and intrinsic ability to target specific CNS pathways. We plan to provide periodic business updates as we advance our R&D pipeline efforts and identify the lead indication for clinical evaluation.”
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
Chief Business Officer
BrainStorm Cell Therapeutics Inc.
Phone: +1 646.666.3188