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Isis Pharmaceuticals to Investigate a Higher Dose of ISIS-SMN Rx in Children with Spinal Muscular Atrophy
Date:11/22/2013

CARLSBAD, Calif., Nov. 22, 2013 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it plans to add a 12 mg cohort to the ongoing Phase 1b/2a study evaluating ISIS-SMNRx in children with spinal muscular atrophy (SMA).  In addition, a 12 mg dose will be included in an open-label extension study for those children who have completed dosing in previous studies.  The addition of the 12 mg cohort will allow for the investigation of this dose in support of the Phase 2/3 registration-directed program planned to begin next year.  

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"We are pleased to be able to increase the dose of ISIS-SMNRx based on the safety and tolerability data we have seen to date in both infants and children with SMA.  We have already begun the infant 12 mg dose cohort and look forward to sharing data from this study early next year.  Considering the encouraging safety profile we have observed in children with SMA in the lower dose cohorts, the evaluation of the 12 mg dose will provide additional information as we move into our Phase 3 program.  We are also pleased that after reviewing the data, the FDA agrees that we can proceed in our investigation of a higher dose," said B. Lynne Parshall, chief operating officer at Isis. "This addition of patients to the ongoing Phase 1b/2a study does not change our plan to report data on the first three cohorts by early next year."

The Phase 1b/2a study of ISIS-SMNRx is an open-label, multiple-dose, dose-escalation study designed to assess the safety, tolerability and pharmacokinetic profile of the drug in children with SMA between the ages of 2-15 who are medically stable. &#
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