BrainStorm announced that the first patients have been enrolled in the Phase 3 clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS) at the Massachusetts General Hospital and UC Irvine Medical Center in California.
The trial is expected to enroll approximately 200 patients and will be conducted at six leading ALS clinical sites in the U.S. The primary outcome measure will be the ALSFR-S score responder analysis. The patient population will be optimized to include the pre-specified subgroups who demonstrated superior outcomes in the NurOwn Phase 2 ALS clinical trial. Top-line data are expected in 2019. More information on the study can be found at www.clinicaltrials.gov.
"NurOwn is a highly innovative and advanced stem cell therapy now being studied in a phase 3 trial in ALS. The support of this trial by the California Institute of Regenerative Medicine (CIRM) highlights the importance of addressing ALS unmet need beyond currently available therapies, which slow disease progression but do not maintain or restore function," said Chaim Lebovits, president and CEO of Brainstorm. "BrainStorm plans to quickly advance the phase 3 trial to confirm promising phase 2 efficacy findings and bring much needed hope to ALS patients and their families."
This trial is supported by a $16 million non-dilutive grant from CIRM. A milestone payment of $5.5 million, representing approximately 30% of the grant, has been received.