BrainStorm Cell Therapeutics is a leading biotechnology developer of adult stem cell therapies, derived from autologous bone narrow cells, for neurodegenerative diseases. The company holds the rights to develop and commercialize its own NurOwn technology through an exclusive, global licensing agreement with Ramot, the technology transfer company of Tel Aviv University.
The company reported today that the European Commission has granted ‘orphan drug’ status for NurOwn. This is BrainStorm’s adult stem cell therapy, consisting of bone marrow-derived mesenchymal stromal cells secreting neurotrophic factors, for treatment of Amyotrophic Lateral Sclerosis (ALS), which is also known as Lou Gehrig’s Disease. The company received a similar designation from the U.S. FDA in 2011.
This is a key development for BrainStorm. Orphan drugs in the European Union receive the benefit from 10 years of market exclusivity after getting marketing approval. Additional benefits include reduced fees for activities such as applications for marketing authorization, inspections and protocol assistance, as well as possible eligibility for European Union grants and other research and development-supporting activities.
Progress is being made on further advancement of NurOwn. The company is currently conducting a Phase IIa dose-escalating trial with a dozen ALS patients at the Hadassah Medical Center, located in Jerusalem, Israel. BrainStorm anticipates launching a Phase II multi-center trial at three leading medical institutions in the United States towards the end of this year, pending FDA approval.
For further information on BrainStorm and its NurOwn adult stem cell treatment for Lou Gehrig’s Disease, please visit www.brainstorm-cell.com
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