A change in pre- to post- treatment slope of 1.25 or more is substantial and clinically important. Production, Pipeline Dr. 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). 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). AstraZeneca has scrapped development of savolitinib as a monotherapy treatment for papillary renal cell carcinoma. 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. exclude terms. 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. Media, Patients & The phase 3 program was one of … Caregivers, About Progressive By then, Mesoblast had already begun testing the allogeneic cell therapy in COVID-19 patients with acute respiratory distress syndrome (ARDS). 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. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056. Last month, the FDA rejected a filing for approval of the cell therapy in children with steroid-resistant graft-versus-host disease (GvHD). MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. Novartis will also provide “support to enable commercial manufacturing scale-up.” Mesoblast has previously said it needed to “substantially scale up manufacturing” to serve the COVID-19 market. The relationship between the companies extends beyond COVID-19. I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial.". +1-201-488-0460. Researchers at Northwestern University have trained an AI algorithm to automatically detect the signs of COVID-19 on a basic X-ray of the lungs. Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723. 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. Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 38723. MS, Patients & In return for a $25 million upfront payment and $25 million investment, plus milestones and royalties, Mesoblast has given Novartis a global license to develop and commercialize remestemcel-L in ARDS. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. In its briefing document, the FDA said the attributes “do not have a demonstrated relationship to the clinical performance of specific [drug product] lots.” The advisory committee backed the drug, but the FDA issued a complete response letter. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford); California Pacific Medical Center (Prof. Robert Miller); Massachusetts General Hospital (Prof. 3 Speen Street, Suite 300, Framingham, MA 01701. The Phase 3 clinical trial's primary efficacy endpoint, a responder analysis evaluating the proportion of participants who experienced a 1.25 points per month improvement in the post-treatment Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope, was powered on assumed treatment response rates of 35% on NurOwn versus 15% on Placebo. The call can be accessed by dialing the numbers below: Toll Free: 877-407-9205International: 201-689-8054. ", "This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials. (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). 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.