APP202601

Application overview Plus
Application code:
APP202601
Application type:
GM Release
Applicant:
SillaJen Biotherapeutics Inc
Applicant postal address:
450 Sansome Street, San Francisco, California, CA 94111, United States
Application state:
Decided
Application decision:
Approved with Controls
Application purpose:
To import for release a genetically modified live-attenuated vaccinia virus (Pexa-Vec) for use in a Phase 3 clinical trial for patients with hepatocellular carcinoma
Decision notified date:
28 October 2015
IBSC Reference:
 
Substances or organisms in application Plus
Name:
Pexa-Vec (pexastimogene devacirepvec; JX-594).
Decision:
Approved with Controls
Synonyms:
 
Approval number:
GMR100003
Trade names:
 
Approval status:
 
Approval expiry date:
 
Application superceded by: