Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia

Inclusion Criteria

• •Written informed consent and child assent, if applicable.
• •FA confirmed by genetic testing with two expanded guanine-adenine-adenine (GAA) repeats.
• •FA functional stage of \>1 to \<5 and ability to walk 25 feet with or without an assistive device.
• •Male or female subject between the ages of 10 and 25 years, inclusive.
• •If female, the subject is not pregnant or lactating or intending to become pregnant during the study, or within 30 days after the last dose of study drug. Female subjects of child-bearing potential must have a negative serum pregnancy test result at Screening, a negative urine pregnancy test result at Baseline, and agree to use a reliable method of contraception throughout the study and for 30 days after the last dose of study drug.
• •History of hypersensitivity to interferon (IFN)-ɣ or E. coli-derived products.
• •Presence of moderate or severe renal disease (estimated creatinine clearance \<50 mL/min) or hepatic disease (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2x the upper limit of normal) as evidenced by laboratory results at Screening.
• •Clinically significant abnormal white blood cell count, hemoglobin, or platelet count as evidenced by laboratory test results at Screening.