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Notification report

Full notification file


General information

Notification Number
B/DE/13/PEI1827

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
07/03/2013

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?
Not known

Has the same GMO been notified elsewhere by the same notifier?
No

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 Name	Genus	Species	Subspecies	Strain	Pathovar
-	Avipox virus	Fowlpox	-	POXVAX-TC	-
N/A	Orthopox virus	vaccinia	N/A	NYCBH	N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
02/04/2013 00:00:00
Remarks: