BCLI - BrainStorm Cell Therapeutics Receives Approval from FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

2024-04-09 07:13:19 ET

DENVER, Colo., Apr 09, 2024 ( 247marketnews.com )- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI ) stated that the U.S. Food and Drug Administration (FDA) provided written approval, under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS), validating the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn.

“We are pleased to have reached an agreement with the FDA on key elements of the Phase 3b trial design that provides a potential path forward towards obtaining regulatory approval,” said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. “We believe that having this SPA in place will help de-risk certain regulatory aspects of the NurOwn clinical program. BrainStorm’s ultimate goal is to provide a new treatment option that can help patients afflicted with ALS, and we believe that the SPA potentially brings us one step closer to this goal. We appreciate the Agency’s engagement and guidance during the SPA process and look forward to moving forward with the study.”

“We have worked with leading neurologists, scientists, and members of the ALS community to create a robust study designed to evaluate the effectiveness and safety of NurOwn. This trial builds on valuable insights from our earlier studies and will enroll people living with ALS who are earlier in the course of their disease. Based on the evidence generated on NurOwn to date, we have a trial that we’re optimistic will be positive.  Over the past year, we’ve assembled an excellent team in clinical development that is highly qualified to execute this trial with excellence.  We’ve been parallel processing to enable us to deliver the first dose in the trial in 2024, and we’re anxious to get started,” stated Stacy Lindborg, Co-CEO of BrainStorm.

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