BrainStorm Cell Therapeutics, a developer of adult stem cell technologies for neurodegenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has approved the Mayo Clinic Human Cellular Therapy Laboratory for production of NurOwn™, BrainStorm’s proprietary autologous mesenchymal stem cells secreting neurotrophic factors (MSC-NTF). BrainStorm plans to continue working with the Mayo clinical team to complete the process which will allow the site to begin enrolling subjects into its phase 2 study of NurOwn™. NurOwn™ is designed to evaluate the safety and efficacy of the transplantation of NurOwn™ in patients with Amyotrophic Lateral Sclerosis (ALS).
In July, BrainStorm submitted to the FDA the results of three pilot manufacturing projects performed at the Mayo Clinic. Each run resulted in the production of NurOwn cells that meet the final product release testing acceptance criteria. Subject to Institutional Review Board approval, the Mayo Clinic will become the third and final site enrolling subjects into Brainstorm’s ongoing ALS clinical trial. In early 2014, both Massachusetts General Hospital (MGH) in Boston and the University of Massachusetts Memorial (UMass) Hospital in Worcester, Mass. began placing subjects in the study.
Brainstorm’s Vice President of Cell Production, Dr. Yossef Levy, said, “This marks the completion of our second successful technology transfer process, and we acknowledge the hard work and dedication of the entire team at the Mayo Clinic in achieving this important milestone.”
Dr. Tony Fiorino, BrainStorm’s Chief Executive Officer, noted, “I applaud the diligence and commitment of both the BrainStorm and Mayo Clinic teams in successfully completing this technology transfer. We are looking forward to the Mayo Clinic joining our Massachusetts’ sites in enrolling subjects into this important study.”
BrainStorm Cell Therapeutics is a biotechnology company involved in the development of unique adult stem cell therapies produced from autologous bone marrow cells for the treatment of neurodegenerative diseases. Along with Ramot, Tel Aviv University’s technology transfer company, BCLI holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement.
For more information on the company, visit www.brainstorm-cell.com
