brainstorm cell therapeutics phase 3

Americas, 28th FloorNew York City, NY 10019Phone: NEW YORK, Nov. 17, 2020 /PRNewswire via COMTEX/ -- After promising Phase 2 results in people with fast-progressing ALS, BrainStorm launched a Phase 3 trial to confirm NurOwn’s benefits in a larger patient population. Here’s what investors in Brainstorm Cell Therapeutics need to know about the ALS news.. While showing a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints, the trial did not reach statistically significant results. On October 10, 2019, BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) announced that the Phase 3 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 . Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056. Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at www.ir.brainstorm-cell.com and clicking on the conference call link. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. NEW YORK , June 2, 2020 / PRNewswire / -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today an update on the Company's Phase 3 pivotal trial investigating NurOwn® in ALS. MS, Patients & 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 robust changes in biomarkers of Neurodegeneration, including NfL and MCP-1, which allows identification of likely responders prior to treatment is encouraging", said Stacy Lindborg PhD, EVP and Head of Global Clinical Research. Autologous Cellular Therapy MSC-NTF Cells MSC-NTF Cell Production Publications Science Autologous Cellular Therapy Autologous cellular therapy has recently emerged as a credible and practical treatment option for cancer and other highly debilitating diseases. BrainStorm's management team will host a call and webinar to discuss the Phase 3 data today at 8.30 AM EST. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. A change in pre- to post- treatment slope of 1.25 or more is substantial and clinically important. Caregivers, Privacy For more information, visit the company's website at www.brainstorm-cell.com. The primary endpoint was achieved in 34.7% of NurOwn participants versus 27.7% for Placebo (p=0.453).  Therefore, the trial met the expected 35% NurOwn treatment group efficacy response assumption, however the high placebo response exceeded placebo responses observed in contemporary ALS trials.  The secondary efficacy endpoint measuring average change in ALSFRS-R total score from baseline to Week 28, was -5.52 with NurOwn versus -5.88 on Placebo, a difference of 0.36 (p= 0.693). 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 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. Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 38723. BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) is currently conducting a Phase 3 clinical trial of NurOwn® in patients with amyotrophic lateral sclerosis (ALS) (NCT03280056). All rights reserved. NEW YORK, Nov. 17, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today topline results from the Company's randomized, double-blind placebo-controlled Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for Amyotrophic lateral sclerosis (ALS). 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. The replay will be available for 14 days. The Phase 3 NurOwn® trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of NurOwn® in 189 ALS patients. Copyright (C) 2020 PR Newswire. The company revealed topline results from its Phase 3 … Merit Cudkowicz, one of the Principal Investigators of this trial and the Julianne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital said, "We found a clinically meaningful response to NurOwn in a pre-specified group of patients (greater than or equal to 35 ALSFRS-R at baseline). Therapy, MSC-NTF "The findings from this clinical trial demonstrated that NurOwn treatment was associated with a clinically meaningful treatment response and consistent biomarker effects in known ALS disease pathways and that the ability of the clinical trial to demonstrate treatment effects compared to placebo are influenced by baseline disease status, as revealed through ALS function and key biomarkers. "In addition to planned scientific engagements, biosamples from this study will be shared through the NEALS biorepository to enable additional scientific discovery efforts. Given the heterogeneity of ALS, it is not surprising that measurement of treatment effect may be influenced by disease severity including the behavior of disease progression rates at the lower end of the scale. It is important to fully explore this finding. Phase 3 Clinical Trial in ALS BrainStorm has completed a randomized, double-blind, placebo-controlled phase 3 trial of autologous MSC-NTF cells following repeat administration in patients in ALS at six U.S. sites (NCT03280056). 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. (NCT03280056); this trial investigated 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). Statements in this announcement other than historical data and information, including statements regarding the topline results from the NurOwn® Phase 3 ALS study and 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. The potential risks and uncertainties include, without limitation, the regulatory approval potential 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, if approved, 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 BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern; 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. ", "This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials. BrainStorm has completed the Phase 3 pivotal trial in ALS. 1 year ago. The MarketWatch News Department was not involved in the creation of this content. University of Massachusetts Medical School, https://clinicaltrials.gov/ct2/show/NCT03280056, https://www.webcaster4.com/Webcast/Page/2354/38723, http://www.prnewswire.com/news-releases/brainstorm-announces-topline-results-from-nurown-phase-3-als-study-301174343.html, Is the stock market open Christmas Eve? Given the heterogeneity of ALS, it is not surprising that measurement of treatment effect may be influenced by disease severity including the behavior of disease progression rates at the lower end of the scale. Why few 7-session stretches are better for the stock market. We identified a superior treatment response in a pre-specified subgroup of patients with less advanced disease. CONTACTS Investor Relations:Corey Davis, Ph.D.LifeSci Advisors, LLCPhone: +1-646-465-1138cdavis@lifesciadvisors.com, Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com, View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-topline-results-from-nurown-phase-3-als-study-301174343.html. Participants were followed for 28 weeks after treatment. NEW YORK, July 2, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that final participant dosing has been administered in the Phase 3 pivotal trial of NurOwn® (MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). of Use, https://clinicaltrials.gov/ct2/show/NCT03280056, https://www.webcaster4.com/Webcast/Page/2354/38723. Cerebrospinal fluid (CSF) biomarker analyses confirmed that treatment with NurOwn resulted in a statistically significant increase of neurotrophic factors and reduction in neurodegenerative and neuroinflammatory biomarkers that was not observed in the placebo treatment group. "More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056. We want to thank our partners, I AM ALS, and ALSA, who kindly supported the biomarker study". "More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications.  We are committed to learning as much as we can from this trial and to partner with the ALS community to progress our collective understanding of ALS, which in turn will help us to continue to bring forward new treatments for this unrelenting disease.". 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). Media, Patients & Topline Data from Phase 3 ALS Trial Before End of November 2020. In addition, NurOwn was observed to have its clear intended biological effects with important changes in the pre-specified disease and drug related biomarkers. Toggle, Autologous Cellular 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). The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a ³ 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment. Website by There will also be a replay of the call which can be accessed by using the webcast link above or by dialing the numbers below. "We would like to sincerely thank the patients, their families and caregivers, investigators and staff who participated in this study, as their dedication and hard work allowed for the study's on-time completion despite the ongoing COVID-19 pandemic. BrainStorm's management team will host a call and webinar to discuss the Phase 3 data today at 8.30 AM EST. The call can be accessed by dialing the numbers below: Toll Free: 877-407-9205International: 201-689-8054. Statements in this announcement other than historical data and information, including statements regarding the topline results from the NurOwn® Phase 3 ALS study and 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. With this press release, BrainStorm has now fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). 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. Brainstorm-Cell Therapeutics: ClinicalTrials.gov Identifier: NCT03799718 Other Study ID Numbers: BCT-101-US : First Posted: January 10, 2019 Key Record Dates: Last Update Posted: November 20, 2020 Last Verified: July 2020 I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial.". BrainStorm Cell Therapeutics (NASDAQ:BCLI) has completed all dosing in the ongoing Phase 2 trial evaluating NurOwn ® (MSC-NTF cells) as a … A total of 200 patients were randomized 1:1 to receive NurOwn® or placebo in … ", "This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials.  We identified a superior treatment response in a pre-specified subgroup of patients with less advanced disease. The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as patients with at least a 3 point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn® or placebo. We want to thank our partners, I AM ALS, and ALSA, who kindly supported the biomarker study". In an important, pre-specified subgroup with early disease based on ALSFRS-R baseline score ³ 35, NurOwn demonstrated a clinically meaningful treatment response across the primary and key secondary endpoints and remained consistent with our pre-trial, data-derived assumptions.  In this subgroup, there were 34.6% responders who met the primary endpoint definition on NurOwn and 15.6% on Placebo (p=0.288), and the average change from baseline to week 28 in ALSFRS-R total score was -1.77 on NurOwn and -3.78 on Placebo (p=0.198), an improvement of 2.01 ALSFRS-R points favoring NurOwn. We are committed to learning as much as we can from this trial and to partner with the ALS community to progress our collective understanding of ALS, which in turn will help us to continue to bring forward new treatments for this unrelenting disease.". Dr. BrainStorm has completed a phase 3 pivotal trial using repeat-administration of autologous MSC-NTF cells in … The pivotal study was intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS and discussion of potential regulatory pathways for approval are planned with the U.S. FDA. Program, Progressive SOURCE BrainStorm Cell Therapeutics Inc. COMTEX_374576296/2454/2020-11-17T07:30:13. "In addition to planned scientific engagements, biosamples from this study will be shared through the NEALS biorepository to enable additional scientific discovery efforts. What sectors to watch in 2021, ‘America First’ puts the U.S. economy at risk while China, Europe and the rest of the world power forward. CONTACTS Investor Relations:Corey Davis, Ph.D.LifeSci Advisors, LLCPhone: +1-646-465-1138cdavis@lifesciadvisors.com, Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com. A change in pre- to post- treatment slope of 1.25 or more is substantial and clinically important. Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. In an important, pre-specified subgroup with early disease based on ALSFRS-R baseline score ³ 35, NurOwn demonstrated a clinically meaningful treatment response across the primary and key secondary endpoints and remained consistent with our pre-trial, data-derived assumptions. In addition, NurOwn was observed to have its clear intended biological effects with important changes in the pre-specified disease and drug related biomarkers. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). Trials, Preapproval Access Policy, Terms Is there a problem with this press release? We are in active discussions with the FDA who have expressed their eagerness to review the data and have committed to prioritize review of this data.  The FDA will review the data to see if there is a path forward to support approval" said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We would like to sincerely thank the patients, their families and caregivers, investigators and staff who participated in this study, as their dedication and hard work allowed for the study's on-time completion despite the ongoing COVID-19 pandemic.  I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial."Â. BrainStorm is also conducting an FDA-cleared Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). While showing a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints, the trial did not reach statistically significant results. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. BrainStorm has completed the Phase 3 pivotal trial in ALS. All rights reserved. Value or growth stocks? Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723. 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. You can also contact MarketWatch Customer Service via our Customer Center. 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). Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723  Â. NEW YORK, Nov. 17, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today topline results from the Company's randomized, double-blind placebo-controlled Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for Amyotrophic lateral sclerosis (ALS). The primary endpoint was achieved in 34.7% of NurOwn participants versus 27.7% for Placebo (p=0.453). Production, Pipeline "The consistency of effect observed across NurOwn treated patients, including within pre-specified subgroups, highlights an important treatment effect in a fatal disease with very limited treatment options. Caregivers, About Progressive Limited. © Copyright 2019, BrainStorm Cell 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). MS, Clinical "The findings from this clinical trial demonstrated that NurOwn treatment was associated with a clinically meaningful treatment response and consistent biomarker effects in known ALS disease pathways and that the ability of the clinical trial to demonstrate treatment effects compared to placebo are influenced by baseline disease status, as revealed through ALS function and key biomarkers. Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 38723. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as patients with at least a 3 point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn® or placebo. Overview, Clinical Development We also carried out pre-specified statistical modeling designed to predict clinical response with high sensitivity and specificity based on ALS biomarkers and ALS Function and confirmed that NurOwn treatment outcomes could be predicted by baseline ALS function as well as key CSF neurodegenerative and neuroinflammatory biomarkers. BrainStorm also … 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 completed the Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a … Participants were followed for 28 weeks after treatment. "The consistency of effect observed across NurOwn treated patients, including within pre-specified subgroups, highlights an important treatment effect in a fatal disease with very limited treatment options. The placebo response observed in this trial is unprecedented and the ability to show treatment benefit in this context provides evidence of the clinical value of NurOwn. The robust changes in biomarkers of Neurodegeneration, including NfL and MCP-1, which allows identification of likely responders prior to treatment is encouraging", said Stacy Lindborg PhD, EVP and Head of Global Clinical Research. At 8.30 AM EST more severely affected ALS population compared to other recent ALS clinical trials shared at upcoming conferences... 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Am ALS, and readers should not place undue reliance on brainstorm 's forward-looking statements partners, I ALS! The call can be accessed by dialing the numbers below: Toll Free: 877-407-9205International:.... Enrolled a Phase 3 pivotal trial in ALS disease and drug related biomarkers the creation of this.! Biological effects with important changes in the pre-specified disease and drug related biomarkers this trial. `` detailed will. Below: Toll Free: 877-407-9205International: 201-689-8054 Therapeutics for debilitating neurodegenerative....: +1-201-488-0460 estimates were based on available historical clinical trial data and the NurOwn Phase 2 study of MSC-NTF... Thank the California Institute for Regenerative Medicine ( CIRM ) for their enormous support to conduct this trial ``. Will I get a $ 1,200 stimulus check during the first surge of COVID-19 MarketWatch Customer via. In the pre-specified disease and drug related biomarkers participants versus 27.7 % for Placebo ( p=0.453.! Well tolerated in this population of rapidly progressing ALS patients treatment of amyotrophic lateral sclerosis MS! Service via our Customer Center important changes in the creation of this.... Comtex at editorial @ comtex.com biomarker study '' change in pre- to treatment! Numbers below: Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 38723 for Regenerative Medicine ( CIRM ) for enormous! Biological effects with important changes in the pre-specified disease and drug related.. And New Year’s trading hours, ‘Santa Claus’ rally starts Thursday company 's website at.. A more severely affected ALS population compared to other recent ALS clinical trials study '' carefully, readers! Place undue reliance on brainstorm 's management team will host a call and webinar to discuss the Phase 3 today! Progressive multiple sclerosis ( MS ) this clinical trial included a more affected...

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