SEC Filings

8-K
AVEXIS, INC. filed this Form 8-K on 12/13/2017
Entire Document
 

Phase 1 Trial: Dose Comparison & Methodology 8 Dose Comparison Stratified into two groups based on age at time of dosing: Less than 24 months of age (n=15) At least 24 months and less than 60 months (n=12) Methodology Cohort 1 (n=3) – Lower Dose/Dose A (6.0 X 1013 vg) Patients less than 24 months of age 4 week interval after each patient to review safety data prior to continuation If safety is established by the DSMB, advance to Dose B Cohort 2 (n=3) – Higher Dose/Dose B (1.2 X 1014 vg) All ages up to 60 months 4 week interval after each patient to review safety data prior to continuation If safety is established by the DSMB, Cohort 2 will be expanded to include 21 additional participants Expanded Cohort 2 (n=21) – Higher Dose/Dose B (1.2 X 1014 vg) Enrollment continues until 12 patients less than 24 months, and 12 patients at least 24 months and less than 60 months, receive Dose B Dose comparison & methodology

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