Back

Notification report

Full notification file


General information

Notification Number
B/ES/09/63

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
16/04/2009

Title of the Project
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 107 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection.

Proposed period of release:
15/10/2009 to 04/02/2013

Name of the Institute(s) or Company(ies)
F. Hoffmann-La Roche, Ltd., Bldg. 74, Grenzacherstrasse 124
4070 Basel
Switzerland;


3. Is the same GMO release planned elsewhere in the Community?
Yes:


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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Non replicative, recombinant vaccinia vector consisting of the modified vaccinia virus of Ankara
(MVA) genome containing inserted transgenes that encode three proteins: the modified forms of
the E6 and E7 proteins (delE6 and delE7) and the human cytokine IL2 (hIL2).

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
MVA	orthopoxvirus	vaccinia virus		Modified Virus Ankara

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
28/09/2009 00:00:00
Remarks: