An animal study published last year highlighted instances of severe, life-threatening toxicity in monkeys and piglets which were given high doses of gene therapy delivered using an AAV9 vector.
The scientists concluded
The present results and those of another recent study utilizing a different AAV9 variant and transgene indicate that systemic and sensory neuron toxicity may be general properties of i.v. delivery of AAV vectors at high doses, irrespective of the capsid serotype or transgene. Preclinical and clinical studies involving high systemic doses of AAV vectors should include careful monitoring for similar toxicities.
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