GenVec, Inc., a clinical-stage gene delivery company, announced that it 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.
"We appreciate the FDA's review and the diligent efforts of our collaborator, Novartis, that have enabled the continuation of the CGF166 trial," said Douglas J. Swirsky, president and CEO of GenVec. "We look forward to the near-term enrollment of new patients and believe that the trial will be completed sometime in 2017 as previously expected."
CGF166 was designed by GenVec to leverage the company's AdenoVerse technology platform for delivery of the atonal gene to sensory cells in the inner ear. These sensory cells are critical to both hearing and balance and can become damaged or destroyed due to aging, infection, trauma from certain medications, or exposure to noise. Approximately 90% of hearing loss is sensorineural. Preclinical experiments have demonstrated the formation of new inner ear sensory hair cells as well as the restoration of hearing and balance function in animal models following treatment with CGF166. CGF166 is being developed by Novartis under a worldwide licensing and collaboration agreement with GenVec to discover and develop novel treatments for hearing loss and balance disorders.
