BrainStorm Cell Therapeutics has signed definitive agreements with Massachusetts General Hospital (Boston, USA) and California Pacific Medical Center (CPMC, San Francisco, USA) to enrol patients in the planned Phase 3 clinical trial of NurOwn in amyotrophic lateral sclerosis (ALS), pending US Food and Drug Administration (FDA) and Institutional Review Board approvals.
Merit Cudkowicz and Robert G Miller are to participate as investigators at Massachusetts General and CPMC, respectively.
“Prior studies of NurOwn showed promising biological and clinical effects,” says Merit E Cudkowicz, professor of Neurology at Harvard Medical School and chief of Neurology at Massachusetts General Hospital. “Based on the results of the Phase 2 trial in which we participated, a larger confirmatory trial that incorporates repeat dosing is warranted. I look forward to working with Brainstorm on this pivotal study.”
“We are all excited about the potential of stem cells for ALS, but the results to date with NurOwn are especially promising,” says Robert Miller, director of the Forbes Norris ALS Research Center at the California Pacific Medical Center. “The clinical impact observed to date, along with potential biomarker findings, make this upcoming Phase 3 trial one of the most exciting ALS clinical trials ever.”