BrainStorm Cell Therapeutics Inc. will be holding a conference call and webcast session to discuss data regarding the company’s phase 2a clinical trial of NurOwn™ for amyotrophic lateral sclerosis (ALS). BrainStorm is a leading biotechnology company in the ALS space that is developing adult stem cell technologies to address neurodegenerative diseases.
The conference call, which will be held on January 5, 2015, will be hosted by Professor Dimitrios Karussis, the lead investigator of the study, and Dr. Moshe Neuman, the Bio-Medical Research Design and CRO. Tony Fiorino, CEO of BrainStorm said in a press release: “We are very excited to share the final results of this study. Professor Karussis presented a very positive and well-received interim analysis of this study at the Joint Congress of European Neurology in June 2014, and the final results include data from several additional subjects and analyses conducted by our independent statisticians. The interim analysis of this study, and results of our prior phase 1/2 study, have shown that a single dose of NurOwn™ is safe and can provide clinically meaningful benefits to ALS patients, such as a reduction in the rate of progression, and in some patients, actual improvements in function. The final results will extend these findings and allow us to move forward with a presentation and publication strategy so that we may share these important data with our medical and scientific colleagues.”
The BrainStorm Phase 2a study was conducted at the Hadassah Medical Center in Jerusalem; it enrolled 14 patients suffering with ALS that received a single intramuscular and intrathecal injection of NurOwn™. The study assessed the efficacy and the safety of 3 ascending doses of the drug. “Subjects in this study underwent a three month run-in period to establish a baseline rate of disease progression, during which bone marrow-derived mesenchymal stem cells were isolated, expanded and differentiated using BrainStorm’s proprietary technology that induces expression of neurotrophic factors. After NurOwn™ administration, subjects were followed for another six months of safety and efficacy assessments,” as noted in a company press release.