BrainStorm Increases Commercial Manufacturing Capacity
BrainStorm Granted GMP Certification for a Second Production Site in Israel
GMP certification of three state-of-the-art cleanrooms more than doubles the Brainstorm’s manufacturing capacity for NurOwn® in Israel
BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, announced today that is has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three state-of-the-art cleanrooms leased by the Company at the Tel Aviv Sourasky Medical Center (“Sourasky Hospital”) in Tel Aviv, Israel. The GMP approval confirms that these cleanrooms are compliant with Israeli GMPs, which are aligned with European Union (EU) GMPs, and more than doubles the Company’s capacity to manufacture and ship NurOwn® into the EU and local Israeli markets.
“We are proud to be the first company to have been granted GMP certificate at the Sourasky Hospital’s Institute for Advanced Cellular Therapies, that hosts a newly built state-of-the-art cleanroom suites to advance our proprietary cellular technology platform in ALS and other neurodegenerative diseases,” said Chaim Lebovits, Chief Executive Officer of BrainStorm. “The GMP certification of these additional cleanrooms means that we now have more than doubled the capacity to supply NurOwn to ALS patients across Israel and Europe. This is critical, as ALS is a truly debilitating disease and patients are in urgent need of new therapies. We remain committed to addressing this unmet need and continue to discuss our clinical data with leading experts as we assess potentially regulatory pathways for NurOwn in various jurisdictions.”
About NurOwn®
About NurOwn®
The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.
About BrainStorm Cell Therapeutics Inc.
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS).
For more information, visit the company’s website at www.brainstorm-cell.com.
