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Notification report


Full notification file


General information

Notification Number
B/PT/16/02

Member State to which the notification was sent
Portugal

Date of acknowledgement from the Member State Competent Authority
29/04/2016

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
Portugal;


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

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

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