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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) announced positive results from their NurOwn Phase 2 clinical trial on neuroprotective biomarkers in progressive multiple sclerosis (MS). An abstract titled 'NurOwn (MSC-NTF) Phase 2 Clinical Trial in Progressive MS' will be presented at the 38th Congress of the European Committee for Treatment and Research in MS from October 26-28, 2022, in Amsterdam. The treatment showed robust increases in cerebrospinal fluid neuroprotective biomarkers, supporting the proposed mechanism of action and clinical outcomes.
BrainStorm Cell Therapeutics Inc. (BCLI) presented new biomarker analyses for NurOwn® at the 5th Annual ALS ONE Research Symposium, highlighting its efficacy in treating amyotrophic lateral sclerosis (ALS). The study indicates that NurOwn affects biomarkers related to neuroinflammation and neurodegeneration across varying disease progression levels. The data reveals a significant treatment effect in less advanced ALS patients, with a preserved functional score of 2 points over 28 weeks compared to placebo. These findings support the need for considering floor effects in clinical endpoint evaluations.
BrainStorm Cell Therapeutics (BCLI) announced the peer-reviewed publication of Phase 2 trial results for its treatment NurOwn in progressive multiple sclerosis (MS) in the Multiple Sclerosis Journal. The study, which included 20 participants, demonstrated NurOwn's safety and showed preliminary efficacy, with 19% of treated patients meeting responder criteria. Key endpoints exhibited significant improvements compared to matched control patients from the CLIMB registry. No major adverse events were reported, confirming NurOwn's favorable safety profile.
BrainStorm Cell Therapeutics (BCLI) has announced plans to submit a Biologics License Application (BLA) to the FDA for NurOwn®, a stem cell therapy aimed at treating amyotrophic lateral sclerosis (ALS). This decision follows new clinical analyses that reinforce the efficacy conclusions from the Phase 3 trial. Financial results for Q2 2022 reveal a net loss of $7.0 million, up from $6.3 million the previous year, with cash reserves decreasing to $12.2 million. The company emphasizes the significance of the upcoming regulatory submission and expresses gratitude towards the ALS community and investors.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will hold a conference call on August 15, 2022, at 8:00 a.m. Eastern Time to discuss financial results for Q2 2022, ending June 30, 2022. The call will feature CEO Chaim Lebovits, along with other executives, providing a corporate update and answering shareholder questions. Participants can submit questions by August 11, 2022, and access the call by dialing specified numbers or via a webcast. BrainStorm focuses on innovative therapies for neurodegenerative diseases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced significant presentations at upcoming ALS and MS conferences in June 2022. Key findings from the ALS Phase 3 trial will be shared at the ENCALS meeting in Edinburgh, emphasizing the importance of addressing floor effects in ALSFRS-R outcomes. At the CMSC meeting in Maryland, three posters will discuss the effects of NurOwn therapy on visual outcomes and biomarkers in progressive MS. These insights aim to enhance understanding of NurOwn's potential benefits for patients with neurodegenerative diseases.
BrainStorm Cell Therapeutics Inc. (BCLI) announced financial results for Q1 2022, reporting a net loss of $5.4 million, down from $6.7 million in Q1 2021. Cash and equivalents decreased to $18.4 million from $22.1 million at the end of 2021. The company is enhancing its leadership team with new appointments, focusing on the advancement of its ALS treatment, NurOwn®. Promising Phase 3 data has been shared, indicating significant effects on ALS biomarkers. BrainStorm continues to engage with ALS experts and plans to present at upcoming conferences.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced senior management appointments on May 12, 2022. Netta Blondheim-Shraga, PhD, is the new VP of Research & Development, tasked with advancing the company's pipeline in cellular therapies. Antal Pearl-Lendner, Adv., joins as Chief Legal Counsel, bringing extensive legal experience. CEO Chaim Lebovits emphasized the importance of these roles in preparing for the company's growth and mission to develop innovative therapies for neurodegenerative diseases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) presented at ISCT 2022 on May 4, 2022, highlighting the superior anti-inflammatory effects of NurOwn-derived exosomes over naïve mesenchymal stem cell-derived exosomes. Preclinical data demonstrated significant reductions in pro-inflammatory cytokines and enhancements in anti-inflammatory cytokines. Notably, treatment with NurOwn-derived exosomes led to a 6.4-fold reduction in MCP-1 and a 3.5-fold increase in IL10. These findings provide critical insights into the potential of NurOwn technology for treating neurodegenerative diseases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced key presentations at scientific conferences in May 2022, focusing on its MSC-NTF exosome technology. New data will be shared at ISCT 2022 in San Francisco (May 4-7) and ISEV 2022 in Lyon, France (May 25-29). Additionally, an analysis of CSF biomarkers from the NurOwn® Phase 3 trial will be presented at the ALS Drug Development Summit in Boston (May 24-26). These insights aim to advance understanding of neurodegenerative disease therapies, particularly ALS.
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