BrainStorm Announces Treatment of Final Patient in US Multicenter Double Blinded Phase 2 ALS Trial

BrainStorm Cell Therapeutics Inc.

, a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the final patient has been treated in its multicenter Phase 2 clinical trial investigating the company's proprietary NurOwn™ stem cell technology. The trial is a double blind, placebo-controlled, clinical trial which targeted enrollment of 48 patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. BrainStorm Cell Therapeutics The study was designed to evaluate the safety and efficacy of transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors ("MSC-NTF" or NurOwn™). The trial is being conducted at the Massachusetts General Hospital (MGH) in Boston, MA, University of Massachusetts Memorial (UMass) Hospital in Worcester, MA, and Mayo Clinic in Rochester, Minnesota. "We are pleased to have successfully completed all transplantations," said principal investigator, Prof. Anthony J. Windebank, MD, "In six months, we expect to complete follow-up visits on the last patients, and we are looking forward to seeing the analysis of the complete results. The initial safety profile has been excellent and the treatment generally well-tolerated – which is a primary goal of the study." "We are proud to announce the completion of dosing of this multicenter study on schedule, which is one of the company's most important milestones to date. Importantly, this is the first trial to compare NurOwn with placebo," said Chaim Lebovits, CEO of BrainStorm. "We are extremely thankful for having the opportunity to collaborate with three top-tier US medical centers – MGH, UMass and Mayo Clinic. And we would like to express our special appreciation and thanks to our team of PI's – Prof. Robert H. Brown, MD, DPhil, Chair of the Neurological Department at UMass, Prof. Merit Cudkowicz, MD, MSc, Chair of the MGH Neurological Clinical Research Institute (NCRI), and Prof. Anthony J. Windebank, MD, Head of the Regenerative Neurobiology Laboratory in the Department of Neurology at Mayo Clinic."