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BrainStorm Highlights Translational Data and Presentations Supporting NUROWN® Technology Platform as a Best-In-Class Strategy in ALS
NurOwn® to be Featured at NEALS and Cell & Gene Meeting on the Mesa Conferences
NEW YORK and PETACH TIKVAH, Israel, Oct. 03, 2018 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative adult stem cell therapeutics for debilitating neurodegenerative diseases, announced today that members of its executive team will present at the Northeast Amyotrophic Lateral Sclerosis (NEALS) Conference in Clearwater, Florida and the Cell & Gene Meeting on the Mesa 2018 Conference in La Jolla, California, both taking place today, October 3, 2018.
Chaim Lebovits, President & Chief Executive Officer, will also be attending the MidCap Investor Event® sponsored by CF&B Communication in Europe on October 8-9, 2018 in Paris, France, and will be available for one-on-one meetings with potential institutional investors. To schedule a meeting, please use the Contact link on BrainStorm's website at www.brainstorm-cell.com.
NEALS Annual 2018 Conference
Poster entitled, “MicroRNA Changes in the NurOwn® Phase 2 ALS Randomized Clinical Trial: Relationship to Neuroprotection and Innate Immunity.”
- Date: Wednesday, October 3, 2018
- Time: 3:45 pm to 5:45 pm Eastern Time (Clearwater, Florida)
- Location: Opal Foyer in the Opal Sands Resort, Clearwater, Florida
- Presenter: Ralph Kern, M.D., MHSc, Chief Operating Officer & Chief Medical Officer
- Key Academic Collaborators:
- Massachusetts General Hospital: James Berry, M.D. and Merit Cudkowicz, M.D.
- University of Massachusetts Medical School: Robert Brown, M.D. and Margaret Ayo Owegi, D.O.
- Mayo Clinic: Anthony Windebank, M.D. and Nathan Staff, M.D., Ph.D.
- For more information: https://goo.gl/zikHA2
Cell & Gene Meeting on the Mesa 2018 Conference
Scientific Workshop entitled, “Successful Strategies in the Design and Delivery of Cell & Gene Therapy Clinical Programs.”
- Date: Wednesday, October 3, 2018
- Time: 7:15 am to 8:45 am Pacific Time (La Jolla, CA)
- Location: Estancia La Jolla Hotel, La Jolla, CA
- Workshop Panel Speakers:
- Peter Altman, Ph.D., President and CEO, BioCardia
- Blake Anson, Ph.D., Director, Strategic Alliances, Fujifilm Cellular Dynamics
- Robert Deans, Ph.D., Chief Technology Officer, BlueRock Therapeutics
- Gisèle Deblandre, Ph.D., Scientific and Project Management Director, MaSTherCell
- Felix Hsu, SVP and Head, Advanced Therapies Unit, WuXi AppTec
- Hardy Kagimoto, M.D., Chairman and CEO, Healios
- Dan Kaufman, M.D., Ph.D., Professor of Medicine, Division of Regenerative Medicine; Director of Cell Therapy, UC San Diego
- María Pascual, VP Regulatory Affairs and Corporate Quality, TiGenix
- Joseph Petroziello, VP, Scientific and Corporate Communications, BrainStorm Cell Therapeutics
- Edward Wirth, M.D., Ph.D., Chief Medical Officer, Asterias Biotherapeutics
- For more information: https://goo.gl/3M4L8b
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading cellular therapy biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform through an exclusive, worldwide licensing agreement. NurOwn® has received Fast Track designation from the U.S. Food and Drug Administration (U.S. FDA) in ALS and has additionally been granted Orphan Status by the U.S. FDA and the European Medicines Agency (EMA). For more information, visit BrainStorm's website at www.brainstorm-cell.com.
About NurOwn® Phase 3 Clinical Program in ALS
BrainStorm is currently enrolling a Phase 3 pivotal trial investigating repeat-administration of NurOwn® in ALS at six clinical sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The study will enroll 200 ALS patients, randomized 1:1 to receive NurOwn® or placebo, and will evaluate the ALS functional rating scale (ALSFRS-R) responder analysis as a primary efficacy outcome measure (NCT03280056). On August 23, 2018, BrainStorm announced a successful pre-specified interim safety analyses by an independent Data Safety Monitoring Board (DSMB). The completion of Phase 3 enrollment is anticipated in 1H2019 and is expected to support a BLA filing for FDA approval of NurOwn® in ALS.
About U.S. Sites for NurOwn® Phase 3 Trial in ALS
- University of California Irvine; Principal Investigator: Namita Goyal, M.D.
- Cedars-Sinai Medical Center; Principal Investigator: Robert Baloh, M.D.
- California Pacific Medical Center; Principal Investigator: Robert Miller, M.D.
- Massachusetts General Hospital; Principal Investigator: James Berry, M.D.
- University of Massachusetts Medical School; Principal Investigator: Robert Brown, M.D.
- Mayo Clinic; Principal Investigator: Anthony Windebank, M.D.
Safe Harbor Statements
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.
LifeSci Advisors LLC