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
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