BioCentury
ARTICLE | Clinical News

Novartis pauses study of GenVec's gene therapy

January 12, 2016 2:45 AM UTC

GenVec Inc. (NASDAQ:GNVC) slid $1.02 (59%) to $0.72 on Monday after disclosing in a regulatory filing that partner Novartis AG (NYSE:NVS; SIX:NOVN) notified the biotech on Friday that it would pause enrollment in a Phase I/II study of CGF166 to treat hearing loss. According to the filing, Novartis intends to conduct a safety review based on a recommendation from the trial's DSMB. GenVec said the trial will continue to collect safety and efficacy data on patients already enrolled.

President and CEO Douglas Swirsky told BioCentury the per-protocol review followed a trio of three-patient cohorts in the dose escalation trial that will inform a dose for the fourth cohort. He declined to discuss the DSMB's specific reason for recommending the pause or the board's safety criteria for the trial, but said GenVec hopes the study will restart enrollment within "a few months" and generate data by 2017, as the company has previously guided. ...