The company expects to release final results of the study in the fourth quarter of 2014 upon completion of statistical analysis. Preliminary interim data from this study were presented In June 2014 at the Joint Congress of European Neurology by principal investigator Professor Dimitrios Karussis of Hadassah (see the company’s June 2, 2014 press release).
"The completion of patients follow-up in this second clinical trial of NurOwn is an important milestone in its clinical development," stated Dr. Yael Gothelf, PhD, Vice President of Scientific and Regulatory Affairs for BrainStorm.
"We are very pleased with the safety and efficacy profile observed to date in this study, and are looking forward to seeing the full set of results."
"I am pleased to bring this second study of NurOwn to a successful conclusion," added Professor Karussis. "I have now treated over 30 ALS patients with NurOwn in two clinical trials, as well as in several compassionate use treatments, and I am enthusiastic about its emerging safety and efficacy profile."
The primary endpoint of this single-arm, single-center dose-ranging study is the safety of a single administration of NurOwn via intrathecal and intramuscular injection. Efficacy measures include the ALS Functional Rating Score-Revised (ALSFRS-R) and forced vital capacity (FVC). A total of 14 subjects were enrolled in this study into three dose cohorts. All subjects underwent a three month run-in period followed by NurOwn administration, then six months of follow-up visits, with safety and efficacy assessments made at each visit.