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Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a pioneering biotechnology company focused on developing advanced autologous stem cell therapies aimed at treating severe neurodegenerative disorders. These include highly debilitating diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS), and Parkinson’s Disease (PD), which currently have limited treatment options.
The cornerstone of Brainstorm's innovative approach is its NurOwn® technology platform. This proprietary technology involves the propagation and differentiation of autologous Mesenchymal Stem Cells (MSCs) into neurotrophic factor (NTF) secreting cells. These MSC-NTF cells are then transplanted at or near the damaged tissue sites, essentially converting MSCs into a living drug delivery system for NTFs that can target specific neurodegenerative diseases.
Brainstorm has demonstrated proof-of-concept in various animal models for diseases including ALS, MS, Parkinson's, Huntington's, and peripheral nerve injuries. The company's commitment to ALS treatment is underscored by the completion of multiple clinical trials, including a Phase 3 trial, which investigated the safety and efficacy of repeat administration of MSC-NTF cells, supported by grants from the California Institute for Regenerative Medicine (CIRM) and the ALS Association.
Most recently, Brainstorm achieved a significant milestone by securing a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the design of a Phase 3b trial of NurOwn in ALS patients. This agreement with the FDA validates the clinical trial protocol and statistical analysis, supporting a future Biologics License Application (BLA) for ALS. The Phase 3b trial aims to enroll up to 200 participants and will involve a double-blind, placebo-controlled period followed by an open-label extension period, focusing on patients earlier in the course of ALS.
Additionally, Brainstorm has fortified its intellectual property portfolio with new patents granted in Europe, Australia, and Israel, enhancing its capability to forge global commercial partnerships for NurOwn. The company's efforts in preclinical research, rigorous clinical trials, and strong collaboration with regulatory agencies and the ALS community underscore its dedication to bringing novel treatment options to patients in need.
Brainstorm's financial condition remains robust, supported by diverse grants and collaborative efforts with advocacy groups. The company continues to advance its pipeline with ongoing clinical trials for progressive MS and plans to expand its research into other neurodegenerative conditions.
For the latest updates on Brainstorm Cell Therapeutics Inc. and its groundbreaking developments, visit their official website or follow their news releases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will hold a conference call on May 16, 2022, at 8:00 a.m. ET to discuss first-quarter financial results and provide a corporate update. CEO Chaim Lebovits will lead the call along with key executives, and participant questions will be addressed. Interested parties can submit questions until 5:00 p.m. ET on May 15, 2022. The call can be accessed via phone or webcast. BrainStorm's autologous MSC-NTF technology aims to address neurodegenerative diseases, with recent advances including a completed Phase 3 trial for ALS.
Brainstorm Cell Therapeutics (NASDAQ: BCLI) announced that President and Chief Medical Officer, Ralph Kern, MD MHSc, will present at the 2022 Virtual Growth Conference hosted by Maxim Group LLC from March 28-30, 9:00 a.m. - 5:00 p.m. EDT. This virtual event will feature executives from various sectors and includes presentations, roundtable discussions, and live Q&A sessions. Investors can sign up to attend. Brainstorm focuses on autologous adult stem cell therapies for neurodegenerative diseases.
Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) reported its fiscal year 2021 financial results, highlighting strong momentum in 2022 with positive clinical data for NurOwn® in ALS patients. Although the Phase 3 trial did not meet primary endpoints, further analyses indicated treatment effects in less advanced ALS patients. The company ended 2021 with approximately $22.1 million in cash. R&D expenses decreased to $15.2 million, while the net loss improved to $24.5 million compared to $31.8 million in 2020. Management expressed confidence in advancing NurOwn® and increasing manufacturing capacity.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) will hold a conference call on March 28, 2022, at 8:00 a.m. ET to discuss financial results for Q4 and the full year ended December 31, 2021, along with a corporate update. CEO Chaim Lebovits will lead the session, addressing questions from the investment community. Notably, BrainStorm's NurOwn® technology is the focus of their clinical efforts in treating neurodegenerative diseases like ALS, having completed pivotal trials supported by grants from CIRM and NMSS.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that its scientific abstract has been accepted for a late-breaking oral presentation at the 2022 MDA Clinical & Scientific Conference, scheduled for March 16, 2022. The presentation, titled 'Relationship of ALS genes and Single-Nucleotide Polymorphisms with Clinical Outcomes in NurOwn Phase 3 ALS Clinical Trial,' will be delivered by Dr. Merit Cudkowicz from Massachusetts General Hospital. This highlights the ongoing advancements in BrainStorm's NurOwn® therapy for neurodegenerative diseases, particularly ALS.
Brainstorm Cell Therapeutics (NASDAQ: BCLI) announced the grant of a new patent by the Brazilian Patent Office for a method to manufacture MSC-NTF cells (NurOwn®), which secrete various neurotrophic factors. CEO Chaim Lebovits emphasized the importance of this patent in enhancing their intellectual property (IP) portfolio, which now includes patents from the US, Canada, EU, Israel, Japan, and Brazil. This development is expected to support future commercial partnerships and regulatory pathways for NurOwn® in South America and globally.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that Dr. Ralph Kern will present a corporate overview at the 12th Annual California ALS Research Summit on January 27, 2022, at 4:45 p.m. ET. The summit, held virtually on January 27-28, focuses on advancing research in neurodegenerative diseases. BrainStorm's NurOwn® technology, which utilizes autologous MSC-NTF cells, aims to treat conditions like ALS and has received Orphan Drug designation from the FDA and EMA. For more details and registration, visit the official summit page.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will present a corporate and clinical overview at Biotech Showcase™ 2022, scheduled virtually on January 10-12 and 17-18. Ralph Kern, M.D., President and CMO, will lead the presentation, which will be pre-recorded for registered attendees. The company is notable for its NurOwn® technology, targeting neurodegenerative diseases. NurOwn® cells, derived from autologous stem cells, aim to deliver neurotrophic factors to affected areas to combat conditions like ALS. BrainStorm has completed significant trials, including a Phase 3 study in ALS and a Phase 2 trial in progressive MS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has announced an extension of the NurOwn® Expanded Access Protocol (EAP) for patients with neurodegenerative diseases, following FDA recommendations. Eligible participants who completed the Phase 3 NurOwn trial can now receive up to 3 additional doses, increasing the total to 9 doses. The decision was informed by new analysis and biomarkers from the Phase 3 study. This initiative aims to provide more treatment options and gather further data on long-term effects.
BrainStorm Cell Therapeutics (BCLI) announced the peer-reviewed publication of Phase 3 clinical data in Muscle and Nerve for its NurOwn® therapy aimed at ALS treatment. While the trial did not achieve statistical significance in its primary and secondary endpoints, analyses indicate a treatment effect in patients with less advanced disease. Key findings revealed larger treatment effects in these subgroups and significant biomarker improvements in neuroinflammation and neurodegeneration. The study reinforces the potential of NurOwn to provide clinical benefits for ALS patients and emphasizes the need for further evaluation.
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