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Notification report

Full notification file


General information

Notification Number
B/NL/14/002

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
01/01/2014

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)
Erasmus MC, Erasmus MC
s-Gravendijkwal 230
Afdeling Urologie
Rotterdam 3015 CE
The Netherlands;


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

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; B/GB/12/R44/01; B/GB/12/R44/01/NI; B/GB/12/R44/01/S;

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 contains 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 Name	Genus	Species	Subspecies	Strain	Pathovar
rilimogene galvacirepvec	Orthopox virus	vaccinia	-	NYCBH	-
rilimogene glafolivec	Avipox virus	Fowlpox	-	POXVAX-TC	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known