Clinical-stage gene delivery company GenVec (Nasdaq: GNVC) said there is no certainty the trials for its lead product CGF166 to treat hearing loss will continue.
The trials were paused earlier in January based on a review of data by the trial's Data Safety Monitoring Board in accordance with criteria in the trial protocol. Novartis (VTX: NOVN) will continue to collect safety and efficacy data on the nine patients currently enrolled in the study before determining whether to proceed with incremental patients.
Douglas Swirsky, president and chief executive of GenVec, said: "While we are disappointed with the pause, as with any first-in-man study, it is important to proceed with care to gain a broad understanding of a product's therapeutic profile. While there is no certainty the trial will continue and timing is also uncertain, we hope enrollment can resume in the coming months and that the trial will be completed sometime in 2017, as previously expected."
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