NEW YORK - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a developer of adult stem cell therapies, has achieved consensus with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) for its Phase 3b clinical trial of NurOwn®, a treatment under investigation for amyotrophic lateral sclerosis (ALS).
The recent Type C meeting with the FDA marks a continuation of progress following the FDA's Special Protocol Assessment (SPA) agreement in April 2024, which clarified the trial's design and endpoints. The SPA is seen as a step towards mitigating regulatory risks.
Chaim Lebovits, President & CEO of BrainStorm, expressed satisfaction with the meeting's outcomes, noting the importance of aligning with the FDA on CMC aspects ahead of the Phase 3b trial. He emphasized the company's commitment to advancing the trial and the potential benefits for the ALS community.
NurOwn has been granted Orphan Drug designation by the FDA and the European Medicines Agency (EMA) for ALS treatment. BrainStorm has previously completed a Phase 3 trial in ALS and a Phase 2 trial in progressive multiple sclerosis (MS), with support from various institutions, including the California Institute for Regenerative Medicine (CIRM) and the National MS Society (NMSS).
This update is based on a press release statement from BrainStorm Cell Therapeutics Inc.
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