Summary Notification

Full notification file

General information

Notification Number
B/DE/05/PEI35

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
16/03/2005

Title of the Project
A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of BIOBYPASS® (AdGVVEGF121.10NH) delivered by NOGA™-guided/MYOSTAR™ catheter in “no option” patients with Class II-IV stable angina

Proposed period of release:
01/12/2005 to 31/12/2006

Name of the Institute(s) or Company(ies)
Hesperion Ltd, GenVec, Inc. (Sponsor) Hesperion Ltd. (legal representative in the Community);

3. Is the same GMO release planned elsewhere in the Community?
Not known

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Adenovirus (recombinant Adenoviral vector)

Information relating to the recipient or parental organisms from wich the GMO is derived

Common Name	Genus	Species	Subspecies	Strain	Pathovar
Adenovirus human serotype 5 (Ad5)

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
12/05/2005 00:00:00
Remarks:

Notification report