The Data Safety and Monitoring Board has conducted its second pre-planned safety review of the phase 2 clinical trial of NurOwn in amyotrophic lateral sclerosis, according to a press release from BrainStorm. This randomised, double-blind, placebo-controlled phase 2 clinical trial is being conducted at three US academic medical centres.
Identifying no safety concerns, the DSMB recommended that the study should continue as planned. The DSMB reviewed safety data up to October 2015, including data for 47 of the 48 patients enrolled in the study. There were no treatment-related serious adverse events recorded during this period. No adverse events, laboratory abnormalities or significant protocol deviations were identified as a cause for concern.
Carlayne Jackson, professor of neurology at the University of Texas Health Science Center, San Antonio, and Chair of the DSMB, states “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, comments “We completed enrolment 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.”
Tony Fiorino, chief medical advisor of BrainStorm says, “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.