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Notification report


Full notification file


General information

Notification Number
B/GB/12/R44/01

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
18/09/2012

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
USA
Contact: Heidi Petersen
Vice President, Regulatory Affairs
001 650 681-4656;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; Denmark; Spain; France; Netherlands; Estonia; Poland; Slovak Republic;

Has the same GMO been notified elsewhere by the same notifier?
Yes

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:
Yes
10/12/2012 00:00:00
Remarks:
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.