BrainStorm Cell Therapeutics has signed an agreement with the University of California Irvine Medical Center (UCI) to start enrolling patients for an upcoming Phase 3 clinical trial evaluating whether NurOwn can improve functional impairment in amyotrophic lateral sclerosis (ALS) patients.
NurOwn is made of mesenchymal stem cells — a type of cell that can transform into other types of cells. NurOwn’s stem cells are collected from the patients themselves and then transformed into cells that secrete neurotrophic factors, which boost nerve tissue growth.
UCI will join Massachusetts General Hospital in Boston and California Pacific Medical Center in San Francisco, as recently announced by Brainstorm, and become the third U.S. center to enroll patients in the planned Phase 3 NurOwn study.
Brainstorm plans to enroll about 200 patients in the trial. Its primary objective is to see if NurOwn can improve functional impairment using the ALS Functional Rating Scale-Revised, or ALSFRS-R.
Researchers will optimize patient population to include the patient profiles that seemed to respond better to NurOwn in the Phase 2 ALS trial (NCT02017912). The Phase 2 trial assessed the safety and efficacy of NurOwn using ALSFRS-R and slow vital capacity, a measure of breathing capacity.
Based on positive results from the Phase 2 trial, NurOwn was shown to provide meaningful benefits compared to placebo. It was also considered safe and well tolerated by patients.
Dr. Namita Goyal will be UCI’s principal investigator. Goyal is an associate clinical professor of neurology in UCI’s Department of Neurology. She specializes in neuromuscular medicine, neurology, and electrodiagnostic medicine.
“We are privileged to have UCI and Dr. Goyal join our pivotal Phase 3 study of NurOwn,” Chaim Lebovits, president and CEO of BrainStorm, said in a press release. “Adding UCI as an enrolling center with Dr. Goyal as Principal Investigator will make the treatment more accessible to patients in California, and we welcome the opportunity to work with this prestigious institution.”
“NurOwn is a very promising treatment with compelling Phase 2 data in patients with ALS; we look forward to further advancing it in clinical development and confirming the therapeutic benefit with BrainStorm,” Goyal added.