Dr. Steve Perrin, CEO and CSO of the ALS Therapy Development Institute (ALS-TDI), recently said “For anyone working in the ALS field, it’s a real time of hope and promise.” He is correct – this is an exciting time! For example, Biogen Idec, Cytokinetics, Incorporated and Neuraltus Pharmaceuticals are just three of a number of companies actively working on developing ALS therapies. Biogen is currently the most advanced company in this respect. They plan to complete their Phase III study of dexpramipexole in over 900 people with ALS early next year. Cytokinetics is currently enrolling people with ALS in the Phase IIb study of tirasemtiv. Cytokinetics expects to know the results of this study by the end of 2013. Neuraltus just announced the results from their Phase II clinical trial of NP001 in people with ALS. The study showed encouraging results in a subset of patients. After discussions with the FDA, Neuraltus has decided to move forward with a Phase III study of their drug, which will start enrolling in 2013. ALS-TDI is teaming up with Novartis to study fingolimod (Gilenya), for the treatment of ALS. Fingolimod is already FDA approved for the treatment of MS. The results of this study are expected by the middle of 2013.
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