We also signed a lease agreement with the Tel Aviv Sourasky Medical Center (Ichilov Hospital) in Tel Aviv, Israel, to produce NurOwn® in three state-of-the-art cleanrooms. 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. The U.S.-Israeli company is … 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. 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. Learn . For example, in a pre-specified participant subgroup with early disease and preserved function based on the ALSFRS-R baseline score, NurOwn® showed the expected numerically superior treatment response compared to placebo. BrainStorm’s autologous MSC-NTF cell therapy has received Fast Track designation from the U.S. Food and Drug Administration (U.S. FDA) in amyotrophic lateral sclerosis (ALS) and has additionally been granted Orphan Status by the U.S. FDA and the European Medicines Agency (EMA). 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. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm’s autologous MSC-NTF cell therapy has received Fast Track designation from the U.S. BrainStorm Cell Therapeutics’ NurOwn technology is a novel adult stem cell therapy that utilizes autologous (“self-derived”) bone marrow cells to address neurodegenerative diseases. Chaim LebovitsChief Executive OfficerBrainStorm Cell Therapeutics Inc. 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. BrainStorm is a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases. Pluristem Therapeutics Inc.’s cell therapy products are designed to treat patients by stimulating their bodies’ own regenerative mechanisms We remain committed to bringing NurOwn® to patients with neurodegenerative diseases as a much-needed treatment option. BrainStorm Cell Therapeutics Inc said on Wednesday it will begin a clinical trial of its experimental stem cell treatment in patients with Alzheimer's disease. 01/11/2016 Releaseecb224ca-fe27-4007-99fa-c69b695d0691_2128040.pdf 103.4 KB. NEW Innovation Stage Become a Sponsor Global Marketplace Company Presentations Start-Up Stadium Academic Campus. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. MSC-NTF cells (NurOwn®) are autologous bone marrow derived mesenchymal stem cells (MSC) induced in culture to secrete high levels of neurotrophic factors (NTFs) that support neuronal growth and survival. 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. Dr. Setboun has extensive experience in the biopharmaceutical industry having held key leadership roles in commercial development and product launches at Biogen. BrainStorm's ALS treatment NurOwn produced no statistically significant difference between the trial group and the control group. BrainStorm’s autologous MSC-NTF cell therapy is investigational and not FDA approved. All rights reserved. Brainstorm Cell Therapeutics [Available On-Demand] June 10-11 & 14-18, 2021 Search. I deeply appreciate the work they've done, and their ability to execute in this challenging COVID environment. 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. We will provide an update when the minutes are finalized. BrainStorm Cell Therapeutics . 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. On April 3, 2020, the Company announced that its wholly owned subsidiary, BrainStorm Cell Therapeutics Ltd., has been awarded a new non-dilutive grant of approximately $1.5 million by the Israel Innovation Authority ("IIA"). 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. To this effect, we engaged in strategic partnerships to expand our Current Good Manufacturing Practice (cGMP) capabilities. The results from this study have been accepted and will be published in a peer-reviewed medical journal in 2021. Our tech transfer to Catalent has already been initiated and will allow for continuous supply of NurOwn® for future clinical trials and initial commercialization. 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. © Copyright 2019, BrainStorm Cell Limited. 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. BrainStorm Awarded $1.5 Million Non-Dilutive Grant for 2020 by the Israel Innovation Authority NEW YORK and PETACH TIKVAH, Israel, April 03, 2020 -- BrainStorm Cell Therapeutics … In addition, he makes $46,680 as Independent Director at Brainstorm Cell Therapeutics. The many scientific and corporate milestones we have achieved this year are a testament to the talent and unwavering commitment of our employees, partners and investigators. Prof. Jacob Frenkel joined us as Chairman of our Board earlier in the year. The grant enables the Company to continue development of advanced cellular manufacturing capabilities, furthers development of MSC-derived exosomes … I am happy to share with you that we have recently had a successful meeting with the FDA regarding Chemistry, Manufacturing and Controls (CMC). IATI (Israel Advanced Technology Industries) is Israel's umbrella organization of high-tech and life science industries. We believe the totality of evidence that we have generated are supportive of NurOwn's clinical benefit. BrainStorm Cell Therapeutics – an Israeli biomed company currently conducting Phase I/II clinical trials on patients suffering from ALS, reported that at least some of the patients treated with its NurOwn cell therapy shown considerable improvement including walking and talking after being unable to do so because of the progress of the disease. In addition to our clinical data review, we are also in active dialog with the FDA around this component of NurOwn's regulatory review. About. News from Israel, the Middle East and the Jewish World . Our +700 members belong to every level and aspect of the ecosystem. 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). Event Menu. Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460. NurOwn has the capability to simultaneously target multiple relevant Alzheimer's disease pathways and bring a comprehensive approach that addresses both neurodegeneration and neuroinflammation. 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 BrainStorm has fully enrolled a phase 2 study of autologous MSC-NTF cells in patients with progressive multiple sclerosis (MS). The company uses a proprietary process to engineer a patient’s cells outside the body to produce and secrete factors that support neuronal survival. Registration. In parallel with the clinical programs to advance NurOwn, Brainstorm is also working to establish the manufacturing capability necessary for a commercial ramp up. BrainStorm Cell Therapeutics, Petach Tikvah, Israel and New York City, NY, USA. Furthermore, phase 3 cerebrospinal fluid neurodegenerative and inflammatory biomarkers were consistently modified by NurOwn treatment, supporting NurOwn's proposed mechanism of action in ALS. Defining a new class of autologous cellular therapeutics. We are thankful to the FDA for prioritizing our IND, as we and the Agency clearly understand the urgency needed for ALS patients. ALS is a progressive neurodegenerative disease. From the Web March 25, 2014, 12:24 pm. We intend to conduct a 52-week, Phase 2 open-label, proof-of-concept clinical trial to evaluate NurOwn in 40 participants with prodromal to mild Alzheimer's disease. The ALS physician, advocacy and patient community feedback on the EAP has been extremely positive. NurOwn™, our proprietary, first-of-its-kind BrainStorm Cell Therapeutics announced that the Phase 3 clinical trial of its cell therapy candidate NurOwn in 200 amyotrophic lateral sclerosis (ALS) patients is fully enrolled and treatment is underway.. 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. 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. The new facility will significantly increase our manufacturing capacity, positioning us to strategically enter the European and Israeli markets. The estimated Net Worth of Malcolm S Taub is at least $585 Thousand dollars as of 14 December 2015. Amyotrophic lateral sclerosis (or … NEW YORK, Dec. 28, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the … The randomized, double-blind and multicenter trial (NCT03280056) is assessing the safety and effectiveness of three administrations of NurOwn into the spinal canal. 07.05.2020 - NEW YORK, N.Y., and TEL AVIV, Israel, May 07, 2020 (GLOBE NEWSWIRE) - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell … 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. I would like to thank you for your continued support. BrainStorm Cell Therapeutics is a biotechnology company developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS) and Parkinson’s Disease (PD). 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. We made important additions to the senior management team during 2020 including Dr. David Setboun as Chief Operating Officer and Dr. Stacy Lindborg as Head of Global Clinical Research. In 2021, we will leverage our strong financial position with over $40 million in cash and our experienced team will continue to be inspired by the ALS patients to bring our innovative treatment option forward while delivering value to our shareholders. NEW YORK & PETACH TIKVAH, (Israel) – December 11, 2013 – BrainStorm Cell Therapeutics Inc. (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that Brainstorm Cell Therapeutics Ltd. was awarded a $800,000 non-dilutive grant from Event Menu. 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. These appointments, as well as the other recent hires, are part of a strategic initiative to build a senior team with proven commercial capabilities, as we transition to potentially becoming a commercial organization. NEW YORK and PETACH TIKVAH, Israel, April 03, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded a new grant of approximately $1.5 million by the Israel … Learn more. Our work with Rapid Reshore & Development, to help BrainStorm establish in-house manufacturing capabilities, will accelerate once a regulatory pathway is clear. I am incredibly proud of the tremendous progress BrainStorm made as a company in 2020. 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. Initiating the EAP immediately after the Phase 3 trial's completion speaks to the promise of NurOwn's phase 3 clinical data, the urgent unmet medical need for ALS patients and our commitment to patients. NEW YORK, Jan. 22, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for debilitating neurodegenerative diseases, today announced that the Israel Patent Office has granted an additional patent titled “Methods of Generating Mesenchymal Stem Cells which Secrete … 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. 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 … We have made excellent progress in our NurOwn clinical program in progressive MS, despite some delays in clinical trial enrollment due to COVID-19 healthcare restrictions. 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 … Website by Chauk. While we did not demonstrate statistical significance in the primary efficacy endpoint in the full study population, pre-specified analyses suggest that NurOwn® has a clinically meaningful treatment effect. 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 … Promote. The next milestone will be the generation of top line results from our fully dosed Phase 2 trial which we expect by the end of first quarter 2021. The Israel Innovation Authority (IIA) has awarded BrainStorm Cell Therapeutics a $2.1 million grant to support the development of NurOwn, an innovative mesenchymal stem cell-based platform to treat neurodegenerative diseases including amyotrophic lateral sclerosis (ALS).. NurOwn was developed by Tel Aviv University professors Dani Offen and the late Eldad … Interactive … The broader objective for NurOwn is to continue to grow a strong body of evidence for NurOwn in ALS, MS in addition to other neurodegenerative diseases. Following the completion of our Phase 3 ALS clinical trial, we recently initiated an Expanded Access Program (EAP) to provide NurOwn® treatment for patients who completed the Phase 3 trial and meet specific eligibility requirements. BrainStorm Cell Therapeutics, Inc. (NASDAQ: BCLI) is a clinical-stage, publicly-traded biotechnology company focused on the development of best-in-class autologous cellular therapeutics for the treatment of highly debilitating neurodegenerative diseases. Nachrichten zur Aktie Brainstorm Cell Therapeutics Inc | A12BXW | BCLI | US10501E2019 Edition: English ... BrainStorm Cell Therapeutics. In addition, we are expanding our pipeline with the application of our exosome platform technology to include new indications that have significant unmet medical need. 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. Attendee Snapshot Event Announcements Frequently Asked Questions. In the pre-clinical study in mice, we demonstrated that intratracheal administration of exosomes extracted from Mesenchymal stem cells resulted in a statistically significant improvement in multiple lung parameters. I want to thank especially the patients and caregivers, who showed a steadfast dedication to our clinical trials despite the pandemic. BrainStorm has completed a phase 3 pivotal trial using repeat-administration of autologous MSC-NTF cells in ALS in the United States. BrainStorm Cell Therapeutics to Conduct Phase 2 Multi-Dose NurOwn® Trial in ALS at Hadassah Medical Center. NurOwn is in clinical … The trial will be conducted at the Brain Research Centers affiliated with the Alzheimer Center Amsterdam, Pitié-Salpêtrière Hospital (Paris), and several other clinical trial sites in the Netherlands and France. BRAINSTORM CELL THERAPEUTICS AKTIE und aktueller Aktienkurs. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cellular therapies to treat unmet medical needs. Plan. Detailed analyses of the full study clinical and biomarker dataset can help demonstrate the potential of NurOwn technology in progressive MS. 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 … All Rights Reserved. Its subsidiary, Brainstorm Cell Therapeutics Ltd. (the Israeli Subsidiary), holds rights to commercialize the technology, NurOwn. Israel’s BrainStorm Cell Therapeutics suffered a major setback last week after poor results from clinical trials caused mare than a 70% drop … This EAP was developed in partnership with the FDA and will take place at the six clinical centers of excellence that participated in the trial. 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