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• The ALS Therapy Development Institute (ALS TDI) said it plans to launch a Phase II trial of TDI 132 (fingolimod/Gilenya) in amyotrophic lateral sclerosis. Gilenya, a first-in-class sphingosine-1-phosphate (S1P) receptor modulator marketed by Novartis AG, of Basel, Switzerland, was approved by the FDA in 2010 to reduce the frequency of clinical exacerbations and delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis. ALS TDI researchers have confirmed that TDI 132 alters the trafficking of certain immune cells through the bloodstream, resulting in lower infiltration into the central nervous system and less damage to motor neurons. Additional experiments at ALS TDI showed treatment with TDI 132 resulted in positive outcomes on several disease measures in preclinical mouse studies. The Phase II trial will determine the safety and tolerability of TDI 132 in individuals with ALS. (See BioWorld Today, June 14, 2010.)