BrainStorm Cell Therapeutics, an Israeli developer of adult stem cell technologies for neurodegenerative diseases, announced that the Data and Safety Monitoring Board (DSMB) met to conduct its first 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 academic medical centers in the U.S.
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The DSMB recommended that the study continue as planned. The DSMB reviewed safety data collected through a cutoff date in January 2015, and did not find any lab abnormalities, adverse events or significant protocol deviations that would be cause for concern.
BrainStorm’s CEO, Tony Fiorino, MD, PhD, 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 ALS 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 intrathecal routes of administration are attractive aspects of NurOwn’s emerging profile.”
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to over 30 patients with ALS in clinical trials conducted in Israel, and is currently being studied in a randomized, double-blind, placebo-controlled clinical trial in the United States.