Full notification file
Member State to which the notification was sent
Date of acknowledgement from the Member State Competent Authority
Title of the Project
Clinical Study BNIT-PRV-301, “A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer”
Proposed period of release:
20/07/2012 to 31/12/2013
Name of the Institute(s) or Company(ies)
BN ImmunoTherapeutics, Inc., 2425 Garcia Avenue
Mountain View, CA 94043
Contact: Heidi Petersen
Vice President, Regulatory Affairs
001 650 681-4656;
3. Is the same GMO release planned elsewhere in the Community?
Belgium; Germany; Denmark; Spain; France; Netherlands; Estonia; Poland; Slovak Republic;
Has the same GMO been notified elsewhere by the same notifier?
If yes, notification number(s):
B/BE/11/BVW2; B/EE/12/01; B/ES/12/14; B/FR/12/GT01; B/GB/11/R44/01; B/GB/11/R44/01/W;
GMO is a:
Identity of the GMO:
PROSTVAC-V/F is a live attenuated viral vector-based investigational vaccine product that is comprised of two component viral vectors, to be used together in a prime-boost vaccination regimen: (1) PROSTVAC-V: Recombinant vaccinia virus that contains a modified gene encoding human prostate-specific antigen (PSA) and genes encoding three human immunological costimulatory molecules: B7.1, intracellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3) (or TRIad of COstimulatory Molecules, TRICOM™); and (2) PROSTVAC-F: Recombinant fowlpox virus that co-expresses the same four human genes as PROSTVAC-V.
PROSTVAC-V: Genus: Orthopox Virus
PROSTVAC-F : Genus: Avipox Virus
Information relating to the recipient or parental organisms from wich the GMO is derived
New York City Board of Health Vaccine (NYCBH)
European Commission administrative information
Consent given by the Member State Competent Authority:
PROSTVAC prostate cancer vaccine trial to take place at 12 sites in England in 2013. A report is to be supplied within 3 months of the administration of the last dose on any unanticipated adverse effects, management of environmental risks and any deviation from the proposed trial plan.