The US Data and Safety Monitoring Board have completed a second pre-planned safety review of Brainstorm’s Phase II clinical trial of NurOwn® for amyotrophic lateral sclerosis and reported no safety concerns.
BrainStorm Cell Therapeutics Inc. (NJ, USA and Israel) recently announced the recommendations of the Data and Safety Monitoring Board (DSMB, USA) regarding their Phase II clinical trial of NurOwn® for amyotrophic lateral sclerosis (ALS). The DSMB conducted a second pre-planned safety review of trial using data collected by October 2015; they reported no safety concerns and advised that the study continue.
Brainstorm is conducting their trial at three major academic medical centers in the USA. The safety review, which included 47 of the 48 enrolled patients, discovered no treatment-related serious adverse events. Additionally, the review did not identify any adverse events, lab abnormalities or protocol deviations that could cause concern
Carlayne Jackson (DSMB and University of Texas Health Science Center
San Antonio, TX, USA) 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.”
“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,” said Chaim Lebovits (BrainStorm Cell Therapeutics Inc.). “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 201
The DSMB plan to complete their third and final assessment once all patients have completed their follow-up visits.
Tony Fiorino (Brainstorm) added: “The successful completion of the DSMB’s second review represents another important milestone in the clinical development of NurOwn®. 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.”
— Written by Daphne Boulicault