BrainStorm Cell Therapeutics has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health (MoH) for its Israeli contract manufacturing facility. The GMP certificate confirms the company's manufacturing site compliance with Israeli GMPs which are recognized as equivalent with EU GMP. The GMP certificate was granted after an inspection of BrainStorm's contract manufacturing facilities.
"BrainStorm received overwhelming demand from patients and physicians in many countries for access to NurOwn. We are pleased to receive this important GMP approval, taking us one step closer to making our therapy available to patients who do not have the opportunity to participate in our U.S. trial," said Dr. Ralph Kern, M.D., Chief Operating Officer & Chief Medical Officer of BrainStorm.
NurOwn utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine. NurOwn is currently being tested in a multi-site Phase 3 clinical trial in the U.S. and, if successful, the results from this trial will submitted to the FDA and other regulatory authorities around the world with the goal of obtaining marketing approval. BrainStorm has completed two single arm clinical trials which established the safety profile of NurOwn and provided indications of a treatment benefit. Additionally, the company has completed a double-blind, placebo-controlled Phase 2 study at three prestigious academic medical centers in the US. In this study, clinically meaningful changes in functioning were observed in patients receiving NurOwn.
"ALS is a debilitating neurodegenerative disease with few treatment options available," said Chaim Lebovits, President & CEO of BrainStorm. "NurOwn is a novel advanced stem cell therapy now being studied in a multi-site Phase 3 pivotal trial at leading ALS centers, and we look forward to making it available to patients through innovative regulatory pathways."