B/BE/18/BVW3 - Summary Notification Information Format (SNIF) Public information presented according to the provisions of Directive 2001/18/EC
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
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