Section 8 – 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | GENVEC, INC. | | | | | | | | Date: December 11, 2013 | By: | /s/ Douglas J. Swirsky | | | | Douglas J. Swirsky
President and Chief Executive Officer |
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