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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.
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.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) is hosting a Key Opinion Leader webinar regarding its Alzheimer's Disease (AD) program today at 8:15 AM ET. The company is expanding its clinical pipeline to develop NurOwn and is initiating a Phase 2 study in AD. This 52-week, open-label trial will evaluate NurOwn in 40 participants with prodromal to mild AD at leading medical centers in the Netherlands and France. The webinar features insights from prominent researchers, aiming to provide an overview of the trial's goals and implications for Alzheimer's treatment.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) completed participant dosing in its Phase 3 trial of NurOwn® for amyotrophic lateral sclerosis (ALS). Approximately 200 participants received either MSC-NTF cells or a placebo over four months. The company anticipates top-line data by Q4 2020, aligning with their enrollment timeline. CEO Chaim Lebovits emphasized this milestone's importance for a potential Biologics License Application. The trial is being conducted at six renowned medical centers, and the company has a recent FDA clearance for a Phase 2 trial in progressive multiple sclerosis.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will host a KOL webinar on its Alzheimer's disease clinical program on July 8, 2020, at 8:15 AM ET. The webinar will feature presentations from Dr. Philip Scheltens and Dr. Bruno Dubois, lead investigators of a Phase 2 trial assessing NurOwn® in 40 participants with prodromal to mild AD. The trial aims to evaluate the efficacy of autologous MSC-NTF cells, designed to deliver neurotrophic factors targeting neurodegenerative disorders. BrainStorm's expansion into Alzheimer's comes after successful developments in ALS and progressive multiple sclerosis.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has announced a new clinical program to develop NurOwn for treating Alzheimer's disease. A multi-national Phase 2 clinical trial is planned to evaluate the safety and efficacy of NurOwn in patients with prodromal to mild Alzheimer's. The trial will include 40 participants receiving three doses over 52 weeks. The company aims to build on its existing ALS program and believes NurOwn can potentially address various neurodegenerative disorders.
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