Israel's BrainStorm Cell Therapeutics, which is developing an adult stem cell treatment for patients with amyotrophic lateral sclerosis (ALS), on Monday named Ralph Kern as chief operating officer. In parallel with the clinical programs to advance NurOwn, Brainstorm is also working to establish the manufacturing capability necessary for a commercial ramp up. We were also pleased to announce a new program utilizing our exosome-based platform-technology for the treatment of severe COVID-19 infection and released proof-of-concept results from a pre-clinical study. Our work with Rapid Reshore & Development, to help BrainStorm establish in-house manufacturing capabilities, will accelerate once a regulatory pathway is clear. Our tech transfer to Catalent has already been initiated and will allow for continuous supply of NurOwn® for future clinical trials and initial commercialization. I am happy to share with you that we have recently had a successful meeting with the FDA regarding Chemistry, Manufacturing and Controls (CMC). BRAINSTORM CELL THERAPEUTICS AKTIE und aktueller Aktienkurs. Plan. BrainStorm has been developing and commercializing NurOwn in partnership with Ramot, the business engagement unit of Tel Aviv University.NurOwn enables the production of growth … Brainstorm Cell Therapeutics has developed a novel stem cell therapy to treat Parkinson’s Disease – using a patient’s own bone marrow stem cells to produce the missing chemical that enables restoration of motor movement. The results from this study have been accepted and will be published in a peer-reviewed medical journal in 2021. Interactive … 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. Israel’s BrainStorm Cell Therapeutics has announced positive top-line Phase 2 data on NurOwn, a customized stem-cell therapy technology to treat amyotrophic lateral sclerosis (ALS). This is a fundamentally different approach to many previous Alzheimer's therapies which have focused on a single target such as tau or beta-amyloid. BrainStorm Cell Therapeutics – NurOwn Background The BrainStorm treatment regimen consists of a person’s own stem cells (called autologous) being removed from bone marrow and then grown outside of the body in the presence of a chemical owned by the company called NurOwn, which aims to increase the stem cells’ ability to make and secrete protective substances called … Promote. 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. Nachrichten zur Aktie Brainstorm Cell Therapeutics Inc | A12BXW | BCLI | US10501E2019 Learn . ALS is a progressive neurodegenerative disease. I want to thank especially the patients and caregivers, who showed a steadfast dedication to our clinical trials despite the pandemic. 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. Brainstorm Cell Therapeutics [Available On-Demand] June 10-11 & 14-18, 2021 Search. People with ALS experience a gradual decline in muscle function and strength as motor neurons — the nerve cells that control muscle movement — die off.NurOwn aims to Mr. Taub owns over 41,742 units of Brainstorm Cell Therapeutics stock worth over $39,344 and over the last 12 years he sold BCLI stock worth over $499,092. Learn more. We are actively evaluating next steps to determine the best path forward with our exosome platform. Looking ahead to 2021, our main focus areas are to reach agreement with FDA on a path for regulatory approval NurOwn® in ALS, to generate top-line results for our Phase 2 MS study in the first quarter, to advance our Phase 2 Alzheimer's disease trial, to expand our exosome-based technology, and to further develop our cellular technology and manufacturing capabilities and infrastructure. These agreements will help to ensure an ongoing cGMP clinical supply of NurOwn® and will be integral to ensuring rapid access for patients following a potential regulatory approval. The new facility will significantly increase our manufacturing capacity, positioning us to strategically enter the European and Israeli markets. 01/11/2016 Releaseecb224ca-fe27-4007-99fa-c69b695d0691_2128040.pdf 103.4 KB. Prof. Jacob Frenkel joined us as Chairman of our Board earlier in the year. Dr. Lindborg is an experienced healthcare executive and globally recognized medical statistician with over two decades of multinational experience in R&D, regulatory drug approvals, strategy development, analytics and big data at Lilly and Biogen. All Rights Reserved. We are diligently pursuing next steps, including active discussions with the United States Food and Drug Administration (FDA) to identify regulatory pathways that may support NurOwn's approval in ALS. BrainStorm Cell Therapeutics to Conduct Phase 2 Multi-Dose NurOwn® Trial in ALS at Hadassah Medical Center. HACKENSACK, N.J. and PETACH TIKVAH, Israel, Jan. 11, 2016 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI), a leading developer of adult stem cell technologies for … The grant enables the Company to continue development of advanced cellular manufacturing capabilities, furthers development of MSC-derived exosomes … BrainStorm Cell Therapeutics (Nasdaq: BCLI), which is developing a stem cell-based treatment for amyotrophic lateral sclerosis ( ALS ), announced yesterday that its NurOwn product had not met the main endpoint of its Phase III … NEW Innovation Stage Become a Sponsor Global Marketplace Company Presentations Start-Up Stadium Academic Campus. As part of our strategy to advance the NurOwn technology and expand our pipeline, we announced earlier this year a new clinical program in Alzheimer's disease. In addition, he makes $46,680 as Independent Director at Brainstorm Cell Therapeutics. CONTACTS  Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138 [email protected], Media: Paul Tyahla SmithSolve Phone: + 1.973.713.3768 [email protected], Copyright © 2020 PR Newswire Association LLC. Defining a new class of autologous cellular therapeutics. BrainStorm's most significant clinical milestone of 2020 was the timely completion of the NurOwn® Phase 3 ALS clinical trial, despite the challenges of COVID-19. NEW YORK, Dec. 28, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI),  a leading developer of cellular therapies for neurodegenerative diseases, today announced the following letter from its Chief Executive Officer, Chaim Lebovits, to its shareholders and the investment community. From the Web March 25, 2014, 12:24 pm. 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