Public register of GMOs field trial locations

Notifications authorised pursuant Title II of Legislative Decree 8 July 2003, n. 224
Competent Authority
: Ministry of Environment,  Land and Sea Protection


PLANTS


 

Notification number Notifier Project title Documents 
 B/IT/04/03 University of Catania Evaluation of transgenic lemon (Citrus limon L. Burm. f.) for resistance to fungal pathogens

Notification summary

Denial of authorisation

B/IT/04/02 Metapontum Agrobios Study of the stability of the transgene and ITS heritability in genetically modified wheat grown in open field conditions

Notification summary

Denial of authorisation

B/IT/04/01 Metapontum Agrobios Safety Assessment in Food and Environment - S:A:F:E

Notification summary

Authorisation Decree

Final Report

Additional info for final report

B/IT/03/01 Metapontum Agrobios Italian Lycopersycon (ITA.LYCO): Biologia avanzata e innovazione di processo al servizio della qualità del pomodoro da industria italiano

Notification summary

Authorisation Decree

Final Report

 


OTHER THAN PLANTS


 

Notification number Notifier Project title Documents
B/IT/19/01

REGENXBIO Inc.

 AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH). Lazio - Sicilia

Notification summary

Authorisation decree

B/IT/17/03

Transgene SA

France

TG6006.01: A phase I/IIa trial to evaluate the safety and efficacy of the combination of the oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first-line treatment of advanced hepatocellular carcinoma (HCC) - Emilia Romagna - Parma

Notification summary

Authorisation decree

 B/IT/17/02  

Transgene SA

France

TG6006.01: A phase I/IIa trial to evaluate the safety and efficacy of the combination of the oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first-line treatment of advanced hepatocellular carcinoma (HCC) - Emilia Romagna - Modena

Notification summary

Authorisation decree

 B/IT/17/01 Targovax Oy A randomised Phase II open-label study with a Phase Ib safety lead-in cohort of ONCOS 102, an immune-priming GM-CSF coding oncolytic adenovirus, and pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma

Notification summary

Authorisation decree

 B/IT/16/02

Clinical trial withdrawn by the notifier
University of Pennsylvania, Philadelphia, United States of America AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH) - Sicilia, Veneto.

Notification summary

Authorisation decree

B/IT/16/01

Clinical trial withdrawn by the notifier
University of Pennsylvania, Philadelphia, United States of America AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH) - Lombardia, Lazio, Sicilia.

Notification summary

Authorisation decree

B/IT/10/01 Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche Improve tools and strategies for the prevention and the control of classical swine fever

Notification summary

Authorisation decree

Final Report

B/IT/09/01 Merial Development of a vaccine against canine leishmaniasis. Efficacy in dogs of a recombinant vaccine candidate against Canine Visceral Leishmaniasis. Evaluation by natural challenge in an experimental kennel

Notification summary

Authorisation decree

Final report