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NEW YORK, March 28, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that two scientific abstracts have been accepted for presentation at the 71stAmerican Academy of Neurology (AAN) Annual Meeting in Philadelphia, PA, May 4-10, 2019.
“We are thrilled that the AAN has selected two Brainstorm Scientific Abstracts for presentation at the 71st Annual meeting,” stated, Chaim Lebovits, CEO of Brainstorm Cell Therapeutics. He added, “We are honored to share our commitment to ALS translational science to many of the most distinguished international leaders in patient-centered neurologic care. Having one of our abstracts selected for oral presentation, during the “Emerging Science Session” underscores our commitment to impactful medical research and to advancing ground-breaking investigational treatments for unmet needs in life-altering and often fatal, neurological diseases.”
“The scientific abstracts selected by the AAN for presentation provide a detailed molecular genetics characterization of neurotrophic factor production by NurOwn® and further correlate cerebrospinal fluid biomarkers with clinical improvement in the completed Phase 2 ALS study,” said Ralph Kern MD MHSc, Brainstorm Chief Operating Officer and Chief Medical Officer. He concluded, “These findings contribute to our overall understanding of the mechanism of action of NurOwn® and provide further evidence linking ALS clinical outcomes to highly relevant disease biomarkers.”
Presentation details are as follows: Title: MODULATION OF CSF CASPASE-3 IN MSC-NTF CELLS (NUROWN®) IN A PHASE 2 ALS STUDY: CORRELATIONS WITH CSF BIOMARKERS AND CLINICAL RESPONSE
Date: Tuesday, May 7, 2019
Time: 12:15 p.m.: Oral data blitz – Emerging Science Session and 12:20 p.m. – 12:45 p.m.: Poster Presentation.
Title: MOLECULAR CHARACTERIZATION OF VEGF SECRETION BY MSC-NTF CELLS (NUROWN®): THERAPEUTIC IMPLICATIONS IN ALS
Date: Thursday, May 9, 2019
Time: 11:30 a.m. – 6:30 p.m.: Poster Session P5.
NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and plans to start enrollment in early 2019.
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.brainstormcell.com.
About Progressive Multiple Sclerosis
MS is an inflammatory disorder in which infection-fighting white blood cells enter the nervous system and cause injury. MS is a demyelinating disorder because the myelin sheath that protects nerves is stripped off during inflammation. Progressive MS is defined by the gradual accumulation of neurological disability independent of relapses, typically with lack of or incomplete recovery. Therapies utilizing regenerative medicine and repair approaches may offer an innovative treatment option. Autologous MSC-NTF cells are bone-marrow derived mesenchymal stem cells (MSCs) propagated and differentiated in culture to secrete high levels of neurotrophic factors (MSC-NTF). In preclinical models, there is increasing recognition that NTFs delivered by autologous MSCs have the potential for immunomodulation, remyelination, and neuroprotection in progressive MS. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.
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