NEW YORK, Feb. 27, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it will present a poster (#M201) outlining the proposed design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS) at the MDA Clinical and Scientific Conference, on Monday, March 4 between 6-8 p.m. at the Hilton Orlando Hotel, Florida. The design is for a two-part, multicenter, Phase 3b study to assess the efficacy and safety of NurOwn in participants with ALS. Eligible patients will initially enter a 24-week randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension period (Part B). The entry criteria will enroll people living with mild-to-moderate ALS. The primary endpoint will be based on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R).
BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn® in ALS
NEW YORK, Dec. 26, 2023 /PRNewswire/ -- Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today provided an update on the grant and allowance of three patent applications for NurOwn® and NurOwn-Exosomes.
NEW YORK, Dec. 7, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the completion of a productive meeting with the U.S. Food and Drug Administration (FDA) to discuss NurOwn®, its investigational treatment for amyotrophic lateral sclerosis (ALS).
NEW YORK, Nov. 20, 2023 /PRNewswire/ --BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the US Food & Drug Administration (US FDA) has granted the company a meeting to discuss the regulatory path forward for NurOwn® in amyotrophic lateral sclerosis (ALS). The meeting is scheduled to take place on December 6, 2023. Brainstorm will discuss plans for a Special Protocol Assessment (SPA) with the FDA to agree on the overall protocol design for a confirmatory Phase 3 trial in ALS.
BrainStorm Cell Therapeutics to Present at 6th Annual ALS Research Symposia
BrainStorm Cell Therapeutics has responded to its failure to win approval in the time-honored fashion. Yet, while the decision to lay off 30% of its staff is classical, the biotech’s reasoning is unusual. Rather than hunker down, BrainStorm is framing the action as a way to accelerate its journey back to the FDA.
NEW YORK, Oct. 18, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the US Food and Drug Administration (FDA) has invited the Company to request an expedited face-to-face meeting to discuss the path forward for NurOwn® as a treatment for amyotrophic lateral sclerosis (ALS). BrainStorm remains committed to the ALS Community and is actively exploring the next steps in support of NurOwn, including publication of emerging clinical data and development of a protocol for an additional clinical study.
Almost a month after FDA advisers delivered a near-unanimous rejection of BrainStorm Cell Therapeutics’ amyotrophic lateral sclerosis drug, the biotech is looking to sit down with the regulator to map out next steps.