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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 Inc. (NASDAQ: BCLI) announced a conference call scheduled for November 15, 2021, at 8:00 a.m. ET to discuss third-quarter financial results and corporate updates. CEO Chaim Lebovits will lead the call, addressing shareholder inquiries following a financial performance overview. Participants can submit questions until November 14, 2021. The company continues to develop its NurOwn® MSC-NTF cellular therapy platform for neurodegenerative diseases, notably receiving Orphan Drug designation for treating ALS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will present its research on MSC-NTF (NurOwn®) exosomes for treating acute lung injury on October 19, 2021, at the NYSCF 2021 Virtual Meeting. The study compares the effectiveness of exosomes from naïve MSCs and those enhanced to secrete regenerative factors. Findings indicate that MSC-NTF exosomes significantly improve oxygen saturation and reduce lung inflammation and fibrosis compared to naïve MSC exosomes. This suggests potential clinical applications for MSC-NTF in lung-related disorders.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced findings from a Phase 2 clinical trial of NurOwn® for progressive multiple sclerosis, presented at the 37th ECTRIMS Congress. The trial achieved its primary endpoint, demonstrating safety and tolerability. Key outcomes included reduced neuroinflammatory biomarkers and improved MS functional measures such as walking and cognitive functions. Notably, 38% of treated patients showed significant walking improvement. BrainStorm seeks FDA guidance for future development steps, indicating potential market impact.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the presentation of a scientific abstract regarding its NurOwn Phase 3 clinical trial at the 2021 Northeast Amyotrophic Lateral Sclerosis Consortium conference. The study investigates biomarkers that predict clinical outcomes in ALS patients. Key speakers include Dr. James Berry and executives emphasizing NurOwn's significance in ALS treatment. The company aims to clarify the therapy's mechanisms, supported by positive results across biomarker domains such as neurodegeneration. Detailed findings will be available on BrainStorm's website following the conference.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that Dr. Stacy Lindborg will present at the 2021 Cell & Gene Meeting on the Mesa, scheduled for October 12-14 and October 19-20. The presentation will focus on the expansion of BrainStorm's technology portfolio, emphasizing autologous and allogeneic candidates for neurological diseases, particularly the completed phase 3 trial of NurOwn® for ALS. The webinar will be available on-demand from October 12. The conference will feature numerous presentations on advancements in cell and gene therapy.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the presentation of a scientific abstract on its Phase 2 study of NurOwn® cells for progressive multiple sclerosis at the 37th ECTRIMS Congress. The trial met its primary endpoint of safety and tolerability, with positive results in neurologic function and cognition. The presentation will occur on October 14, 2021, featuring Dr. Jeffrey Cohen from the Cleveland Clinic. CEO Chaim Lebovits and CMO Ralph Kern emphasized the importance of these findings for advancing therapies for progressive MS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported its financial results for the first quarter ended June 30, 2021, indicating a net loss of approximately $6.3 million, down from $7.4 million the previous year. Cash and equivalents totaled around $35.0 million, a decline from $40.0 million as of March 31, 2021. The company successfully received GMP approval for expanded manufacturing capacity in Israel and has strengthened its NurOwn® intellectual property with multiple patents in key markets. Ongoing discussions with ALS experts aim to enhance the regulatory strategy for NurOwn.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received GMP approval from the Israel Ministry of Health for three advanced cleanrooms at Sourasky Hospital, doubling its manufacturing capacity for NurOwn®. This expansion is crucial for supplying ALS patients in Israel and Europe, addressing an urgent need for new therapies. The company remains committed to advancing its cellular technology for neurodegenerative diseases, with ongoing discussions on regulatory pathways for NurOwn®.
BrainStorm Cell Therapeutics (BCLI) will conduct a conference call on August 5, 2021, at 8:00 a.m. ET, to discuss second-quarter financial results ending June 30, 2021, and provide a corporate update. CEO Chaim Lebovits will lead the call, supported by key executives, and encourage shareholders to submit questions by August 4, 2021.
This call aims to enhance transparency with investors and will be accessible via dial-in numbers and a webcast link.
Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced the grant and allowance of several patents for its NurOwn® technology aimed at treating neurodegenerative diseases. These patents, effective across major markets including the U.S., E.U., Canada, Israel, and Hong Kong, strengthen Brainstorm's intellectual property portfolio. CEO Chaim Lebovits emphasized the significant potential of NurOwn in addressing unmet medical needs, particularly for diseases like ALS and MS. The company's innovative MSC-NTF cell therapy has received Orphan Drug designation from the FDA and EMA.
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