NEW YORK and LOS ANGELES, Jan. 21, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, will present at the 10th Annual California ALS Research Summit, January 24-25 at Cedars-Sinai Medical Center, Los Angeles, California.
Dr. Kern will provide an update on BrainStorm’s Phase 3 ALS Clinical Trial on Friday, January 24, 10:30 -11:10 AM PT, during the session: “CIRM funded Stem Cell Clinical Trials in California – Updates.”
Dr. Kern stated, “This prestigious Summit works to increase, expedite and promote the amount and level of amyotrophic lateral sclerosis (ALS) research done in California that has been reinforced and amplified by the international ALS scientific and medical community. I am pleased to have the opportunity to share all that BrainStorm has accomplished in our fully enrolled Phase 3 clinical trial of NurOwn® (NCT03280056).”
Chaim Lebovits, President and CEO of BrainStorm, stated, “California continues to be a global leader in stem cell research and scientific funding. Due to California’s commitment to stem cell scientific investigation, BrainStorm is at an inflection point as we bring our investigational therapy, NurOwn, toward the submission of a biological license application. In July 2017, BrainStorm was awarded a grant of $15.9 million from the California Institute for Regenerative Medicine (CIRM) and three of California’s most prestigious medical centers: University of California, Irvine, Cedars-Sinai Medical Center, and California Pacific Medical Center have contributed immensely to advancement of NurOwn. Everyone at BrainStorm is proud Dr. Kern will have the opportunity to present to the ALS community of California all that has been accomplished due to their ongoing support and encouragement.”
About The California ALS Research Summit:
The California ALS Research Summit is the tenth annual gathering of researchers, investigators, clinicians, biotech companies, government representatives, partner organizations, and advocates in ALS and related fields in the State of California.
The purpose of the Summit is to help increase, expedite and promote the amount and level of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's Disease) and related research done in California; and to foster networking, collaboration and cooperation among investigators, their peers and their colleagues to identify, develop and deliver new and effective treatments, ideas and, ultimately, cures for ALS.
The result of our efforts is an ongoing roadmap for ALS research in California, which will provide the basis for partnering within the state and other supporters to further studies to find new treatments and ultimately a cure for the disease.
NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.
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 has fully enrolled 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. For more information, visit BrainStorm'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.
CONTACTS
Corporate:
Uri Yablonka
Chief Business Officer
BrainStorm Cell Therapeutics Inc.
Phone: 646-666-3188
uri@brainstorm-cell.com
Media:
Sean Leous
Westwicke/ICR PR
Phone: +1.646.677.1839
sean.leous@icrinc.com
Or:
Katie Gallagher
LaVoieHealthSciences
Phone: + 1 617-374-8800 x109
kgallagher@lavoiehealthscience.com