FDA removes clinical hold on early-stage study of Novartis' hearing loss candidate CGF166

• The FDA lifts its clinical hold on Novartis' (NYSE:NVS -1%) Phase 1/2 study assessing CGF166 in patients with severe-to-profound hearing loss after the Data Safety and Monitoring Board recommended that the trial continue. The agency stopped the trial in January of this year in accordance with criteria in the study's protocol that required a review of the results. Top-line data should be available in 2017.
• CGF166 is an advanced adenoviral vector engineered to deliver the human atonal gene to sensory cells in the inner ear. Novartis licensed it from GenVec (GNVC -2.4%) in January 2010.