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NEW YORK, Sept. 06, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in the development of innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, will present scientific data at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS, www.ectrims-congress.eu), September 11-13th in Stockholm, Sweden.
BrainStorm is conducting a Phase 2 open-label, US-based, multicenter study of repeated intrathecal administration of NurOwn® in participants with Progressive Multiple Sclerosis. The Phase 2 study will evaluate validated MS efficacy outcome measures as well as innovative and validated CSF and serum biomarkers. The efficacy outcome data presented at this ECTRIMS meeting provides a natural history cohort matched to the phase 2 patient population. The phase 2 MS study is actively enrolling participants and should be fully enrolled by early 2020.
Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm said, “We are very pleased to have the opportunity to participate at ECTRIMS, the largest annual International Congress devoted to basic and clinical research in Multiple Sclerosis (MS). The BrainStorm team looks forward to meeting with many of the leading scientists in MS and sharing our ideas with the many researchers who are dedicated to changing the lives of those with MS.”
Meeting and Presentation Details:
ECTRIMS Late Breaking News ePoster:
|Title: Disability improvement assessed by multiple sclerosis functional composite in progressive MS patients from the CLIMB Study|
|Authors: T. Chitnis, M. Rosso, H. Yano, B. Glanz, M.C. Manieri, R. Kern, S. Ward, M. Mehra, H. Weiner, B. Healy, Brigham and Women's Hospital, Ann Romney Center for Neurologic Diseases and Massachusetts General Hospital, Boston, MA, BrainStorm Cell Therapeutics, NY, NY.|
|Session: Poster Session 3|
|Date: Friday, 13 September 2019|
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, 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.
Chief Business Officer
BrainStorm Cell Therapeutics Inc.