“It was exciting to see how expeditiously the FDA reviewed our application to test Gilenya in ALS patients,” said ALS TDI CEO and CSO Steve Perrin, Ph.D. regarding the approval of a Phase IIa clinical trial to test the safety and tolerability of Novartis’ multiple sclerosis drug Gilenya (also known as fingolimod). In 2011, ALS TDI began preclinical testing of Gilenya in mice because the drug’s mechanism of action seemed relevant. The results of these preclinical studies were positive, and in early 2012 ALS TDI announced that Gilenya might be a potential drug for people with ALS. ALS TDI plans to start enrolling patients soon at sites located in Massachusetts, California, Georgia, and Texas.
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