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FDA Lifts Clinical Hold On CGF166

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Additional Information

Additional Relevant Details GenVec was notified by its collaborator, Novartis, that the Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.   As previously disclosed, in January 2016 Novartis informed GenVec that enrollment in the trial had been paused in accordance with criteria in the trial's protocol. In April 2016, Novartis informed GenVec that the trial's Data Safety Monitoring Board (DSMB) recommended that the trial continue after reviewing safety and efficacy data from the nine patients who have been enrolled in the trial to date.
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Catalyst Date
Occurred on:
Jul 25, 2016
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Related Keywords Clinical Hold, Cgf166, Hearing Loss, Adenoverse, Phase 1/2 Clinical Trial