A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck

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Study title: 
A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck
Long title: 
A phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy
Date receipt dossier: 
13 Jun 2018
EU record number: 
B/BE/18/BVW3
EudraCT number: 
2016-004161-68
Company / Sponsor: 
Oragenics, Inc.
Phase: 
II
Treated organism: 
Humans
Indication category: 
Adverse events associated with cancer treatment
Disease: 
Oral mucositis in subjects with cancers of the head and neck
Therapeutic approach: 
anti-inflammatory treatment
Genetic modification: 
Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1).
Method of transfer of nucleic acid of interest: 
-
Administered biological material: 
GM Lactococcus lactis
Route of administration: 
Oral mouth rinse
Locations in Belgium: 
UZ Leuven ; Grand Hôpital de Charleroi ; Institut Jules Bordet (Brussels) ; UZ Antwerpen ; UZ Brussel ; AZ Sint-Maarten (Duffel)
Nr of subjects: 
A total of 200 participants will be involved in the study worldwide: 140 in the US and 60 in Europe divided equally between Belgium and Germany. Therefore, in Belgium and in Germany, 15 subjects per country will be recruited in the AG013 treatment group.
Foreseen duration: 
Approximately from July 2018 until June 2019
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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