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BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI): Pioneering Stem Cell Therapies for Neurodegenerative Diseases
BrainStorm Cell Therapeutics Inc. is a biotechnology company at the forefront of developing innovative autologous stem cell therapies for debilitating neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson’s disease (PD). With limited treatment options available for these conditions, BrainStorm is addressing critical unmet medical needs through its proprietary NurOwn® technology platform.
Core Technology: NurOwn® and MSC-NTF Cells
At the heart of BrainStorm’s innovation is NurOwn®, a groundbreaking process that transforms mesenchymal stem cells (MSCs) into neurotrophic factor-secreting cells (MSC-NTF). These cells are designed to deliver neuroprotective and anti-inflammatory factors directly to the site of neuronal damage, offering a targeted therapeutic approach. This platform essentially converts MSCs into a “living drug delivery system,” capable of addressing the complex pathology of neurodegenerative diseases.
NurOwn® has shown promise in preclinical and clinical studies, demonstrating potential benefits such as reducing neuroinflammation and neurodegeneration biomarkers. Key findings include reductions in neurofilament light (NfL), a biomarker associated with neuronal damage, and improvements in anti-inflammatory and neuroprotective markers. These results underscore the multifaceted therapeutic potential of NurOwn®.
Clinical Development and Regulatory Milestones
BrainStorm has completed a Phase 3 trial for NurOwn® in ALS, supported by grants from organizations such as the California Institute for Regenerative Medicine (CIRM) and the ALS Association. Although initial results faced challenges, post-hoc analyses identified a strong signal of efficacy in early-stage ALS patients, leading to the design of a Phase 3b trial. The company has secured a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA), de-risking the regulatory pathway for this pivotal study.
The upcoming Phase 3b trial will focus on early-stage ALS patients, leveraging insights from previous studies to optimize trial design and endpoints. This trial is expected to provide robust evidence of NurOwn’s efficacy and safety, paving the way for a Biologics License Application (BLA).
Strategic Partnerships and Manufacturing Capabilities
To support its clinical and commercial ambitions, BrainStorm has partnered with Pluri Inc., a leader in GMP-compliant cell manufacturing. This collaboration ensures high-quality production of NurOwn® while complementing BrainStorm’s existing manufacturing facilities in Israel. The company is also exploring additional U.S.-based manufacturing options to scale production for future commercial distribution.
Expanding the Pipeline: Exosome Technology
Beyond NurOwn®, BrainStorm is advancing its proprietary exosome technology, which leverages MSC-NTF-derived exosomes as nano-carriers for targeted delivery of bioactive molecules. These exosomes exhibit unique immunomodulatory and neuroprotective properties, offering potential applications in respiratory and neurodegenerative diseases. The recent Notice of Allowance from the U.S. Patent and Trademark Office strengthens BrainStorm’s intellectual property portfolio, positioning the company as a leader in exosome-based therapies.
Commitment to Patients and the Future
BrainStorm’s mission is deeply rooted in improving the lives of patients with neurodegenerative diseases. By focusing on scientific rigor, regulatory alignment, and strategic partnerships, the company is poised to deliver transformative therapies. As it prepares for the Phase 3b trial and explores new applications for its exosome platform, BrainStorm continues to exemplify innovation and resilience in the biotechnology sector.
With a robust pipeline, strong intellectual property, and a commitment to addressing unmet medical needs, BrainStorm Cell Therapeutics Inc. is a key player in the quest to revolutionize treatments for neurodegenerative diseases.
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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