Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent
United Kingdom

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 characterization

GMO is a:
DNA Virus

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
Species: Vaccinia
PROSTVAC-F : Genus: Avipox Virus
Species: Fowlpox

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-Avipox virusFowlpoxN/APOXVAX-TCN/A
N/AOrthopox virusvacciniaN/ANew York City Board of Health Vaccine (NYCBH)N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
10/12/2012 00:00:00
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.