Recently announced expansion of NurOwn® development program, adding Alzheimer’s disease KOL webinar today at 8:15 AM ET
NEW YORK, July 8, 2020 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, is hosting a Key Opinion Leader (KOL) webinar on its Alzheimer’s Disease (AD) program today at 8:15 AM Eastern Time. The Company recently announced that it is expanding its clinical pipeline to develop NurOwn® and begin a Phase 2 study in AD.
The webinar features presentations by two lead investigators in the Company’s planned international Phase 2 trial: Philip Scheltens, M.D., Ph.D., Professor of Cognitive Neurology and Director of the Alzheimer Centre at VU University Medical Center in Amsterdam, Netherlands; and Bruno Dubois, M.D., Ph.D., Professor of Neurology at the Neurological Institute of the Salpétrière University Hospital in Paris, France. The 52-week, open-label, proof-of-concept clinical trial is designed to evaluate NurOwn in 40 participants with prodromal to mild AD. It will be conducted at VU University Medical Center (Amsterdam), Pitié-Salpêtrière Hospital (Paris), and other clinical trial sites in the Netherlands and France.
To participate in the webcast, please use the link below and to view a copy of the accompanying slide presentation, please refer to the Events & Presentations section of the Company’s website. The presentation will be followed by a question-and-answer session with Professors Scheltens and Dubois and with BrainStorm management.
Philip Scheltens, M.D., Ph.D. received both his M.D. degree (1984) and his Ph.D. in Magnetic Resonance Imaging in Alzheimer’s Disease (1993) from VU University in Amsterdam. His main clinical and research interests are Alzheimer’s disease, vascular dementia, frontotemporal dementia, magnetic resonance imaging, PET imaging and fluid biomarkers. He has been the national principal investigator (PI) for over 35 studies, including several Phase 1-3 multicenter clinical trials. Dr. Scheltens founded the Alzheimer Centere at VU University in 2000, and co-founded and assumed the chairmanship of the board of Deltaplan Dementie, the Dutch national plan against dementia, in 2013. He is also the co-editor-in-chief of Alzheimer’s Research & Therapy, one of the leading journals in this field.
Bruno Dubois, M.D., Ph.D., is Professor of Neurology at the University Salpêtrière Hospital in Paris, Sorbonne-University and Director of the Institute for Memory and Alzheimer Disease (IM2A). He also directs the Expert Memory Center Paris-Sud and the Research INSERM Unit on Cognition and Neuroimaging in Brain Diseases at the Institut du Cerveau et de la Moelle épinière (ICM, Brain and Spine Institute) in Paris. He is Coordinator of the National Reference Centers for Rare Dementias and Young-Onset Alzheimer Disease and of the Paris Center of Excellence in Neurodegeneration (CoEN). Dr. Dubois has published more than 600 peer-reviewed articles on anatomical and biochemical studies of the central cholinergic systems in rodents and humans, as well as on cognition in patients with dementia, with special focus on memory, executive functions and frontal lobe behaviors, and biomarkers in neurodegenerative disorders. He leads an international working group of experts (IWG) on the new criteria for Alzheimer disease. He is principal or co-investigator of several research programs focusing on AD, prodromal AD, and dementia in Parkinson’s disease as well as the EU Joint Programme on Neurodegenerative Disease (JPND), IMI-EPAD and IMI- AMYPAD. Dr. Dubois is President of the French Society of Neurology and a member of the National Academy of Medicine.
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 (NTFs). 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 recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019.
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) 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.