BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Outcomes at the Virtual New York Stem Cell Foundation Conference

Rhea-AI Summary

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the presentation of a scientific poster on NurOwn® exosomes for treating ARDS at the NYSCF Conference on October 20, 2020. The study demonstrated significant improvements in lung function and reduced inflammation in a mouse model of ARDS, suggesting NurOwn exosomes may be a viable therapy for COVID-19 related lung complications. CEO Chaim Lebovits reaffirmed the company's commitment to advancing their therapeutic pipeline while preparing for the pivotal Phase 3 ALS clinical trial data release.

Positive

• NurOwn exosomes showed statistically significant improvement in lung function and reduction in inflammation in ARDS model.
• Potential for NurOwn exosomes as a therapeutic option for COVID-19 induced ARDS.
• Ongoing commitment to advancing ALS clinical trial and regulatory submission activities.

Negative

• None.

NEW YORK, Oct. 19, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced the presentation of a poster titled, "MSC-NTF (NurOwn®) Exosomes: A Novel Therapeutic Modality in the Mouse LPS-induced ARDS model Analysis" at the NYSCF Conference Meeting, being held virtually. The scientific poster will be presented on October 20.

POSTER HIGHLIGHTS:

• One of the most severe complications of the current COVID-19 pandemic is acute respiratory distress syndrome (ARDS). ARDS is caused by increased amounts of pro-inflammatory cytokines, leading to lung damage and loss of lung function.
• Results from a study in a mouse model of lipopolysaccharide (LPS)-induced ARDS showed that intratracheal administration of NurOwn (MSC-NTF cells) derived exosomes resulted in a statistically significant improvement in multiple lung parameters. These included the clinically relevant factors: functional lung recovery, reduction in pro-inflammatory cytokines and attenuation of lung damage.
• These positive preclinical results suggest that MSC-NTF exosomes may be suitable as a therapy for COVID-19 induced ARDS, and are more effective at combatting ARDS physiological, pathological, and biochemical symptoms than exosomes isolated from non-induced MSCs.

"Brainstorm continues to explore the full potential of our proprietary platform cell technology and we are very proud of the therapeutic pipeline advances made by our scientific teams," said Chaim Lebovits, CEO of Brainstorm, "At the same time we remain fully focused on delivering top-line data for our pivotal phase 3 ALS clinical trial as planned and completing the necessary activities to submit a BLA following data review."

About NYSCF

The NYSCF Conference is the leading scientific meeting on translational stem cell research. It annually convenes over 500 participants from academia, industry government, non-profits, and patient groups.

About NurOwn®

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 has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 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 (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites 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 (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment in August 2020. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement 

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, 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, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; 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.

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CONTACTS 

Investor Relations:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Phone: +1-646-465-1138
cdavis@lifesciadvisors.com

Media:
Paul Tyahla
SmithSolve
Phone: +1-973-713-3768
Paul.tyahla@smithsolve.com 

 

 

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SOURCE Brainstorm Cell Therapeutics Inc

FAQ

What are the results of BrainStorm's recent ARDS study presented at NYSCF Conference?

The study indicated significant improvements in lung function and reduced inflammation from NurOwn exosomes in a mouse model of ARDS.

When was BrainStorm's poster on NurOwn exosomes presented?

The scientific poster was presented at the NYSCF Conference on October 20, 2020.

What is the significance of the ARDS study for BrainStorm?

The study suggests that NurOwn exosomes may be a promising therapy for ARDS caused by COVID-19, enhancing BrainStorm's therapeutic portfolio.

What is BrainStorm's next step regarding ALS clinical trials?

BrainStorm is focused on delivering top-line data for its pivotal Phase 3 ALS clinical trial.

What does the approval of NurOwn exosomes mean for BrainStorm?

The positive preclinical results enhance the potential for NurOwn exosomes as a treatment option, potentially benefiting BrainStorm's market position.