Fast-Track Designation Granted to NurOwn for Treating ALS

The U.S. Food and Drug Administration (FDA) has granted Fast-Track designation to BrainStorm Cell Therapeutics’ NurOwn for treating ALS. The company’s stem cell therapy consists of autologous mesenchymal stem cells that have undergone differentiation to secrete neurotrophic factors to support and repair damaged neurons. NurOwn is currently being tested for ALS in a Phase II clinical trial ongoing at 3 ALS medical centers in the US (see April 2014 news story). The Fast Track designation will provide BrainStorm Cell Therapeutics with more frequent meetings with the FDA and potentially earlier submission of the New Drug Application, which together will help accelerate the development of this therapy for this unmet need.

The U.S. Food and Drug Administration (FDA) has granted Fast-Track designation to BrainStorm Cell Therapeutics’ NurOwn for treating ALS. The company’s stem cell therapy consists of autologous mesenchymal stem cells that have undergone differentiation to secrete neurotrophic factors to support and repair damaged neurons. NurOwn is currently being tested for ALS in a Phase II clinical trial ongoing at 3 ALS medical centers in the US (see April 2014 news story). The Fast Track designation will provide BrainStorm Cell Therapeutics with more frequent meetings with the FDA and potentially earlier submission of the New Drug Application, which together will help accelerate the development of this therapy for this unmet need.

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