FDA lifts clinical hold on GenVec/Novartis' CGF166 in hearing loss

25 July 2016

The US Food and Drug Administration has lifted its clinical hold on a Phase I/II trial of CGF166, a treatment for patients with severe to profound hearing loss which is being developed by Swiss pharma giant Novartis (NOVN: VX) under a licensing agreement with USA-based GenVec (Nasdaq: GNVC).

In January of this year, Novartis informed the clinical stage gene delivery company that enrollment in the trial had been paused in accordance with criteria in the trial's protocol.

This pause was based on a review of data by the trial's Data Safety Monitoring Board (DSMB) in accordance with criteria in the study protocol.

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