Brainstorm Cell Therapeutics has been awarded a US$16 million grant from the California Institute for Regenerative Medicine (CIRM) to support the pivotal Phase 3 study of NurOwn, for the treatment of amyotrophic lateral sclerosis (ALS).
CIRM is the World’s Largest Institution Dedicated to Cell Therapies.
Maria Millan, interim president and chief executive officer of CIRM commented, “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 enrol approximately 200 patients and will be conducted at six top ALS clinical sites in the USA. 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.