Brainstorm Cell Therapeutics announced that the California Institute for Regenerative Medicine (CIRM) has awarded Brainstorm a grant of $16 million to support the pivotal Phase 3 study of NurOwn, for the treatment of amyotrophic lateral sclerosis (ALS).
The grant from CIRM is a significant endorsement of the potential for Brainstorm’s novel approach to treat ALS using adult stem cells. CIRM is the World’s Largest Institution Dedicated to Cell Therapies.
“We are honored to be awarded this CIRM grant, and appreciate the support of CIRM in the development of NurOwn,” said Chaim Lebovits, President and CEO of Brainstorm. “This substantial award provides further support for our technology and clinical program, and recognizes the importance of developing effective treatments for patients afflicted with ALS.”
Dr. Maria Millan, interim President and CEO of CIRM commented, “ALS is a devastating disease with an average life expectancy of less than five years and individuals afflicted with this condition suffer an extreme loss in quality of life. They lose the ability to walk, dress themselves, speak, swallow and breathe. CIRM is partnering with Brainstorm to follow up on the Company’s promising phase 2 trial in patients with ALS. CIRM’s mission is to accelerate stem cell treatments to patients with unmet medical needs and, in keeping with this mission, our objective is to find a treatment for patients ravaged by this neurologic condition for which there is currently no cure.”
Brainstorm is in the advanced stages of planning a Phase 3 clinical trial investigating NurOwn in ALS. The trial is expected to enroll approximately 200 patients and will be conducted at 6 top 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 faster-progressing patients who demonstrated superior outcomes in the NurOwn Phase 2 ALS trial.