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GNVC > SEC Filings for GNVC > Form 8-K on 11-Dec-2013All Recent SEC Filings

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Form 8-K for GENVEC INC


11-Dec-2013

Other Events


Item 8.01 Other Events.

On December 4, 2013, the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) unanimously approved the protocol for initiation of a Phase 1 study of CGF166, an adenoviral vector engineered to express the human atonal gene, in patients with severe hearing loss. CGF166 utilizes GenVec's proprietary adenovectors technology and is being developed by the Novartis Institute for Biomedical Research, a subsidiary of Novartis AG, under a research collaboration and license agreement with GenVec.

The protocol, "A Three-part, Multicenter, Open Label, Single Dose Study to Assess the Safety, Tolerability, and Efficacy of Intralabyrinthine (IL) CGF166 in Patients with Severe Hearing Loss," was the subject of an in-depth review and public discussion at the RAC meeting. A replay webcast of the meeting is expected to be available on the NIH website later this month and accessible at http://videocast.nih.gov/launch.asp?18200.

GenVec expects that an investigational new drug application, or IND, will be filed for CGF166 in January 2014.

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