BrainStorm Cell Therapeutics has signed definitive agreements with Massachusetts General Hospital and California Pacific Medical Center (CPMC) to enroll patients in the planned Phase 3 clinical trial of NurOwn in amyotrophic lateral sclerosis (ALS), pending FDA and Institutional Review Board approvals. Drs. Merit Cudkowicz and Robert G. Miller, both Key Opinion Leaders in ALS, have agreed to participate as investigators at Mass. General and CPMC, respectively.
"It is a privilege to be working with Mass. General once again and to welcome CPMC as a new clinical site in our Phase 3 trial," said Chaim Lebovits, President and CEO of BrainStorm. "We are excited to be taking the final steps towards U.S. launch of this trial and will be announcing the participation of other hospital sites in the near future."
Dr. Merit Cudkowicz is the Julianne Dorn Professor of Neurology at Massachusetts General Hospital, at Harvard Medical School. She directs the Massachusetts General Hospital ALS Program and the Neurological Clinical Research Institute (NCRI; formerly the NCTU). She is one of the founders and previous co-director of the Northeast ALS Consortium (NEALS), a group of 109 clinical sites in the United States and Canada dedicated to performing collaborative academic led clinical trials in ALS. In conjunction with the NEALS consortium, she planned and completed many multi-center clinical trials in ALS.
Dr. Robert Miller is Director of the Forbes Norris ALS Research Center at the California Pacific Medical Center (CPMC) in San Francisco. He was the lead author of the AAN evidence-based practice parameters for managing the disease, published in 1999 and the updated in 2009. He has been active in ALS clinical trials and is the chair of the Western ALS Study Group, an organization that has carried out numerous clinical trials in ALS. He was the chair of the ALS Outcomes Research group, ALS CARE, and later ALS Connection, resulting in numerous publications about quality of care and outcomes in ALS. He has been involved with several collaborative efforts to find better markers for disease progression and better treatments for ALS.