Listening in hearing

GenVec Inc. and partner Novartis AG are blazing a new trail in more ways than one with a gene therapy candidate delivered directly to the inner ear to treat sensorineural hearing loss. Just getting to the point of dosing their first patient last month required working with FDA to identify the necessary preclinical data, define and test the appropriate enrollment criteria and come up with a way to evaluate clinically significant changes tied to regrowing sensory hair cells - something that has never been done in humans.

Indeed, the U.S. Phase I/II trial of CGF166 is the first to evaluate a gene therapy for hearing loss, and the first to evaluate delivery of any drug to the inner ear...