FDA: BrainStorm's ALS Cell Therapy Lacks Substantial Data For Submission

 

• The FDA's initial review concluded that current data from BrainStorm Cell Therapeutics Inc's (NASDAQ: BCLI) NurOwn Phase 3 trial in amyotrophic lateral sclerosis (ALS) does not sufficiently provide the threshold of substantial evidence to support the marketing application.

• Also, the FDA advised that this recommendation does not preclude Brainstorm from proceeding with a marketing application submission.

• "Brainstorm will first consult with principal investigators, ALS experts, expert statisticians, regulatory advisors, and ALS advocacy groups to assess the benefit/risk of a BLA submission before making a final decision," said Chaim Lebovits, CEO.

• NurOwn, autologous MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells that have been expanded and differentiated ex vivo.

• The cells can deliver immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

https://finance.yahoo.com/news/fda-concludes-brainstorms-als-cell-140159192.html