BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that the Data and Safety Monitoring Board (DSMB) conducted its second pre-planned safety review of the randomized, double-blind, placebo-controlled phase 2 clinical trial of NurOwn in amyotrophic lateral sclerosis (ALS) that BrainStorm is conducting at three major academic medical centers in the US.
The DSMB recommended that the study should continue as planned and identified no safety concerns. The DSMB reviewed safety data collected through a cutoff date in October 2015, which included 47 of the 48 patients enrolled in the study and, importantly, no treatment-related serious adverse events (SAEs) were reported. Beyond this, the DSMB did not identify any adverse events, lab abnormalities or significant protocol deviations that would be cause for concern.
Dr. Carlayne Jackson, professor of neurology at the University of Texas Health Science Center San Antonio and chair of the DSMB, stated “Based on the laboratory data and reported adverse events to date, we are recommending continuation of the existing protocol and have no concerns about the safety or tolerability of both the intrathecal and intramuscular injections.”
BrainStorm’s CEO, Chaim Lebovits, commented “We are pleased that the DSMB has again identified no concerns following their review of the safety data accumulated for the NurOwn study, consistent with the initial review. We completed enrollment in this trial in August of this year, and currently expect top-line data to be available prior to the end of the second quarter of 2016.”
“The successful completion of the DSMB’s second review represents another important milestone in the clinical development of NurOwn,” said Dr. Tony Fiorino, chief medical advisor of BrainStorm. “The safety and tolerability of intrathecal and intramuscular injections appears to be excellent, and we hope to see a similar profile as we begin giving multiple doses of NurOwn in our next planned study.”
The DSMB is an independent group of experts who review the accumulated safety data in ongoing clinical trials in order to safeguard the safety and interests of participating patients. This was the second of three planned DSMB reviews of this clinical trial. The third is expected to occur after all patients in the study have completed their scheduled follow-up visits.