BrainStorm has announced that the Data and Safety Monitoring Board (DSMB) met to conduct its first safety review of the randomised, double-blind, placebo-controlled phase II clinical trial of NurOwn in amyotrophic lateral sclerosis being conducted by BrainStorm at three academic medical centres in the USA.
The DSMB reviewed safety data collected through a cut-off date in January 2015, and did not find any lab abnormalities, adverse events or significant protocol deviations that would be cause for concern, and thus recommended that the study continue as planned.
BrainStorm’s chief executive officer, Tony Fiorino, commented “We are gratified that the DSMB has found no concerns after having reviewed the safety data accumulated for the study through January. This extends our prior safety observations made in the two prior amyotrophic lateral sclerosis studies of NurOwn conducted in Israel at Hadassah Medical Center. To date, the safety of NurOwn observed in our clinical trials has been quite good, and the ease of administration and tolerability of both intramuscular and the ease of administration and tolerability of both intramuscular and intravenous routes of administration are attractive aspects of NurOwn’s emerging profile.”