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Notification report


Full notification file


General information

Notification Number
B/RO/17/02

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
03/04/2017

Title of the Project
PHASE 3 STUDY OF ADXS11-001 ADMINISTERED FOLLOWING CHEMORADIATION AS ADJUVANT TREATMENT FOR HIGH RISK LOCALLY ADVANCED CERVICAL CANCER: AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence

Proposed period of release:
01/09/2017 to 31/12/2023

Name of the Institute(s) or Company(ies)
INVENTIV HEALTH CLINICAL ROMANIA SRL, INVENTIV HEALTH CLINICAL ROMANIA SRL Bvd. Eroilor, no.22,
county 5, 050513 Bucharest, Romania;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Spain; Netherlands; Poland; Romania;

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

If yes, notification number(s):
B/ES/17/02;

GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
The GMO is an attenuated Listeria monocytogenes strain which has been engineered to express the tLLO-E7 fusion protein. The E7 protein sequence was derived from Human Papilloma Virus 16. The Listeria monocytogenes strain is named axalimogene filolisbac, and is also known as ADXS11-001. Axalimogene filolisbac is a clinical drug product administered to patients for cancer treatment.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
XFL7Listeriamonocytogenes--serovar 1/2 a

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known