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Notification report


Full notification file


General information

Notification Number
B/ES/20/03

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
20/01/2020

Title of the Project
The OVAL Study: A Randomized,
Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent
Platinum-Resistant Ovarian Cancer


Proposed period of release:
01/05/2020 to 31/12/2022

Name of the Institute(s) or Company(ies)
Vascular Biogenics Ltd. (VBL Therapeutics), ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
United Kingdom; Hungary; Poland; Bulgaria;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Order: Adenovirus
Genus: Mastadenovirus
Species: human adenovirus
Strain: serotype 5
Common name: Ad5

The GMO/IMP VB-111 is an anti-angiogenic agent based on an adenovirus vector. It is a
non-replicating E1 deleted, Adenovirus 5, carrying a transgene expressing a pro-apoptotic
human Fas chimera under the control of a modified murine promoter (PPE-1-3x). The
transgene is specifically expressed in angiogenic endothelial cells. The GMO is intended for
therapeutic purposes to target solid tumors using a dual mechanism of action: antiangiogenesis
and stimulation of immune system.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
human adenovirus serotype 5Mastadenovirushuman adenovirussubgroup Chuman serotype 5 (Ad5)-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known