FrenchFries
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BrainStorm Cell Therapeutics - October 6, 2014
"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.
NurOwn™ is currently being studied in a randomized, double-blind, placebo-controlled phase 2 clinical trial conducted at three sites in the United States (see Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS - Full Text View - ClinicalTrials.gov for further details). Enrollment in this study began in June 2014 and is expected to continue through mid-2015.
"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.
NurOwn™ is currently being studied in a randomized, double-blind, placebo-controlled phase 2 clinical trial conducted at three sites in the United States (see Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS - Full Text View - ClinicalTrials.gov for further details). Enrollment in this study began in June 2014 and is expected to continue through mid-2015.
