ALS Phase I/II Stem Cell Study in Int’l Spotlight
Rasheda Ali Walsh, daughter of the legendary Muhammad Ali, was briefed by CEO Dr. Adrian Harel about the ALS Phase I/II stem cell clinical trial being conducted by BrainStorm, during a recent visit to BrainStorm’s labs in Petach Tikvah. Ali Walsh, is an internationally known advocate for promoting research and awareness of neurodegenerative diseases and a member of the Advisory Board of BrainStorm.
The interim results of the Phase I/II ALS (Amyotrophic Lateral Sclerosis) clinical trial, indicate that autologous transplantation of the cell therapy was well-tolerated, appears to be safe for use, and did not present any undue risks to the study participants.
Professor Dimitrios Karussis of the Neurology Department at Hadassah Medical Center Jerusalem and Principal Investigator of the trial, noted that “although this is an interim safety summary report documenting achievement of the study’s primary endpoint, we cannot ignore some possible promising indications of clinical efficacy observed in single patients, such as a tendency towards improvement in some of the major ALS Functional Rating Scale variables.”
The company also reported that in some patients this pilot study demonstrated a tendency toward stabilization in some parameters in the ALS Functional Rating Scale.
The interim data was reported on the first group of patients, all of whom suffer from early stage or progressive ALS, also known as Lou Gehrig’s disease. All patients enrolled were transplanted with NurOwn either intramuscularly or intrathecally.
Professor Robert Brown, Chair of Neurology at the University of Massachusetts Medical School and a world renowned expert in neuromuscular genetics and ALS, added, “This interim report clearly documents that Brainstorm’s NurOwn stem cell therapy is safe.”
Orphan-drug designation for NurOwn™ has been granted by the US Food and Drug Administration, and BrainStorm is awaiting FDA approval to expand its ALS clinical development to the United States. BrainStorm has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS human clinical trials at these institutions.