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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 October 15, 2020, at 8:00 a.m. EDT to discuss third-quarter financial results for the period ending September 30, 2020, and provide a corporate update. The call will feature CEO Chaim Lebovits, alongside key executives who will answer shareholder questions. Participants can submit questions until October 13, 2020. The company is noted for its NurOwn technology, which targets neurodegenerative diseases and has several ongoing clinical trials.
On September 30, 2020, BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) presented a poster on the Phase 3 clinical trial design of NurOwn® for ALS at the virtual Annual Northeast ALS Meeting. The trial is designed to evaluate the effects of NurOwn® on rapidly progressing ALS patients, building on promising Phase 2 results. The study aims to confirm the efficacy of NurOwn® and assess its duration through repeated administrations. Topline data from the trial is expected in Q4 2020, marking a significant step towards potential FDA approval.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the appointment of William K. White as Senior Vice President, Head of Market Access and Pricing. With over 25 years of experience in product commercialization, White aims to ensure market access for NurOwn®, currently in a Phase 3 trial for ALS. CEO Chaim Lebovits emphasized the importance of White's background in securing patient access to innovative therapies, crucial for the potential FDA approval of NurOwn®. The company is focused on bringing revolutionary stem cell treatments to patients suffering from neurodegenerative diseases.
Brainstorm Cell Therapeutics (NASDAQ: BCLI) announced the granting of a new patent by the Japanese Patent Office for its method of generating mesenchymal stem cells secreting neurotrophic factors, crucial for treating neurodegenerative diseases. The patent covers key neurotrophic factors such as BDNF, GDNF, HGF, and VEGF. This development strengthens Brainstorm’s intellectual property portfolio, enhances its ability to secure commercial partnerships in Japan, and supports its ongoing Phase 3 trial for ALS treatment. The company aims to leverage this patent for strategic growth and market presence.
On August 25, 2020, BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the acceptance of a clinical abstract showcasing a correlation between MRI measures and functional improvements in patients with progressive multiple sclerosis (MS). This data will be presented at the MSVirtual2020 meeting on September 11-13. The analysis involved 48 participants and revealed significant differences in MRI data between those with improved versus stable or worsening function, specifically using the 9-hole peg test and timed-25-foot-walk metrics. CEO Chaim Lebovits emphasized the potential implications for clinical outcomes in their ongoing Phase 2 trial of NurOwn®.
On August 19, 2020, BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the publication of a manuscript regarding the effects of its NurOwn stem cell therapy on T and B regulatory cells in ALS. The research highlighted significant findings, including a notable reduction in inflammatory biomarkers and increased circulating T regulatory cells in previous clinical studies. The preclinical experiments demonstrated a decrease in interferon-g secretion and induction of regulatory cells, which may support NurOwn's therapeutic potential in ALS and other neuroinflammatory diseases.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that Dr. Ralph Kern will present a corporate overview at the 40th Annual Canaccord Genuity Growth Conference, held virtually from August 11-13, 2020. One-on-one meetings with institutional investors will also be available on the presentation day. The event will take place on August 13, 2020, at 3:30 PM ET, with a webcast accessible for viewing. BrainStorm develops adult stem cell therapies, notably its MSC-NTF cells for ALS, which have received Orphan Drug status from the FDA and EMA. Phase 3 trials are ongoing, aiming for FDA approval.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported its Q2 2020 financial results, highlighting a net loss of $7.39 million, up from $4.90 million in Q2 2019. Despite COVID-19 challenges, the firm completed enrollment in its Phase 3 ALS trial, with data expected by November 2020. BCLI is also advancing its NurOwn platform into new areas, including Alzheimer's, with a Phase 2 trial planned in Europe. The company has approximately $37.5 million in available funding as of July 31, 2020, reflecting growth from prior periods.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will hold a conference call on August 5, 2020, at 8:00 a.m. EDT to update shareholders on its Q2 financial results and provide corporate updates. CEO Chaim Lebovits will discuss the timeline for the Phase 3 trial of NurOwn® in ALS while Dr. Revital Aricha will cover recent advancements in R&D, including a preclinical study on COVID-19 treatment. The company has recently completed enrollment for its pivotal ALS trial and received FDA clearance for a Phase 2 trial in progressive MS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced progress in its development of an innovative exosome-based platform technology targeting severe COVID-19 infection. Key findings from a mouse model study showed that intratracheal administration of exosomes derived from MSCs using NurOwn® technology led to significant improvements in lung parameters, including functional recovery and reduced lung damage. The company plans to discuss the results during its Q2 earnings call on August 5 and is considering a clinical trial for ARDS based on these promising preclinical results.
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