BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it 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."
"Prior studies of NurOwn showed promising biological and clinical effects," said Merit E. Cudkowicz, MD, MSc, 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," said Dr. Robert Miller, Director of the Forbes Norris ALS Research Center at the California Pacific Medical Center in San Francisco. "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."
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.
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.
