Liver Toxicity in Gene Therapy Trials Could Merit Stricter Entry Criteria
An FDA advisory committee offered up lower vector doses, stricter exclusion criteria, and long-term animal studies to grapple with liver toxicities associated with adeno-associated virus (AAV) vector-based gene therapies. During the second of four sessions on AAV safety, the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) weighed evidence of hepatotoxicity — ranging from liver […]