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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 on March 30, 2023, at 8:00 a.m. ET to discuss financial results for the fourth quarter and full year ended December 31, 2022, along with corporate updates. The call will feature leaders including President Chaim Lebovits and Co-CEO Stacy Lindborg, PhD. Shareholders are invited to submit questions by March 26, 2023. Call details include toll-free and international participant numbers, with a webcast available at this link. BrainStorm develops therapies for neurodegenerative diseases, notably for ALS using its proprietary NurOwn® technology.
BrainStorm Cell Therapeutics (BCLI) announced the donation of serum and cerebrospinal fluid samples from its Phase 3 ALS trial of NurOwn® to the NEALS biorepository. This initiative is part of a $500,000 grant received from The ALS Association and I AM ALS to support biomarker research. The samples were collected over a 20-week period, enhancing the understanding of ALS progression and treatment effects. The collaboration aims to facilitate new breakthroughs in ALS treatment, with key stakeholders expressing optimism about the research potential.
On January 5, 2023, BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that its management will present a corporate and clinical overview at Biotech Showcase™ 2023 on January 9 at 10:30 a.m. PT in San Francisco. Presenters include President and CEO Chaim Lebovits and Co-CEO Stacy Lindborg. Attendees can join in person or via webcast. The company specializes in adult stem cell therapies for neurodegenerative diseases, with its NurOwn® technology receiving orphan drug designation for treating ALS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has promoted Dr. Stacy Lindborg to Co-Chief Executive Officer as part of a strategic initiative to enhance leadership and expertise. Dr. Lindborg brings over 25 years of pharmaceutical experience and will focus on advancing the regulatory process for NurOwn, a novel stem cell treatment for ALS. Chaim Lebovits retains his role as President and CEO, and Dr. Ralph Kern will retire but continue as a member of the Scientific Advisory Board. This leadership transition aims to position the company for future growth and success.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that the FDA granted a Type A meeting to discuss the refusal to file letter regarding its New Biologics License Application (BLA) for NurOwn® aimed at treating ALS. Scheduled for January 11, 2023, the meeting intends to clarify the next steps in the approval process. CEO Chaim Lebovits expressed optimism about discussing clinical evidence and potentially holding an Advisory Committee Meeting. The Phase 3 trial results indicated a statistically significant clinical response in a specific subgroup of ALS patients, alongside positive biomarker data.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) submitted a Type A Meeting Request to the FDA to address a refusal to file letter regarding its New Biologics License Application for NurOwn® in treating ALS. The meeting is expected within 30 days of receipt. The refusal letter points to issues related to chemistry, manufacturing, controls, and clinical data. CEO Chaim Lebovits emphasizes the importance of this meeting to advance NurOwn and anticipates a clear path toward an FDA Advisory Committee Meeting, which is crucial for therapy approval.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) reported its third-quarter financial results for 2022, revealing a net loss of approximately $6.9 million, compared to $5.3 million in Q3 2021. The company announced plans to request a Type A meeting with the FDA to address a recent refusal to file letter for its Biologics License Application (BLA) for NurOwn in ALS treatment. In clinical updates, promising biomarker analyses from ongoing trials were shared, highlighting NurOwn's potential efficacy in ALS and progressive MS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) received a refusal to file letter from the FDA concerning its New Biologics License Application (BLA) for NurOwn, aimed at treating ALS. The FDA suggested that BrainStorm could request a Type A meeting to discuss the refusal. CEO Chaim Lebovits expressed disappointment but reaffirmed commitment to NurOwn's advancement. Despite the Phase 3 trial not meeting its primary outcome, some participants showed beneficial effects, indicating potential for further investigation and dialogue with the FDA.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will host a conference call on November 14, 2022, at 8:00 a.m. ET, to discuss its third-quarter financial results and corporate updates for the period ending September 30, 2022. The call will feature CEO Chaim Lebovits and key executives who will answer questions from participants. Interested individuals can submit questions by November 10, 2022, and join via phone or a live webcast. BrainStorm is known for developing stem cell therapies for neurodegenerative diseases and is actively involved in clinical trials for its NurOwn® technology.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) presented new post-hoc analyses from the NurOwn Phase 3 ALS trial at the NEALS meeting, highlighting a clinically meaningful treatment effect despite the ALSFRS-R floor effect. The analyses accounted for participants with low baseline scores, revealing a treatment advantage in those with less advanced ALS. NurOwn treatment showed a nominally significant clinical response compared to placebo in pre-specified subgroups. These findings, alongside biomarker data indicating consistent treatment effects, bolster confidence in NurOwn's potential for ALS therapy.
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