Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Clinical Study JX594-HEP024, “A Phase 3 Randomized, Open-Label Study Comparing Pexa-Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

Proposed period of release:
01/07/2016 to 31/12/2020

Name of the Institute(s) or Company(ies)
PPD Gobal Ltd, Sucursal em Portugal
Avenida da Liberdade, 180-A, 4º Dto.
1250-146 Lisboa

3. Is the same GMO release planned elsewhere in the Community?
Austria; Germany; Finland; France; United Kingdom; Italy; Poland;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Orthopoxvirus
Species: Vaccinia virus (VV)
The GMO is a viral suspension of the recombinant virus Pexa-Vec (formerly called JX-594 in previous submissions performed in European Union (EU) countries by Transgene S.A.). Pexa-Vec is an oncolytic therapeutic vaccinia virus (Wyeth strain) designed to selectively replicate in and destroy cancer cells, while at the same time stimulating a systemic antitumoral immune response through the expression of its transgene, human granulocyte-macrophage colony stimulating factor (hGM-CSF) in the context of tumor lysis. Three genetic modifications are present in Pexa-Vec:
1 thymidine kinase (TK) gene deactivation,
2 GM-CSF insertion under control of the synthetic early-late promoter and,
3. lac-Z gene insertion under control of the p7.5 promoter.
Pexa-Vec is a therapeutic anticancer candidate to be administered in patients with advanced stage of cancers.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
N/Aorthopoxvirusvaccinia virusN/AN/AN/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known