Phase 2 study to evaluate AG013 for the attenuation of oral mucositis
Research type
Research Study
Full 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
IRAS ID
251855
Contact name
Claire Paterson
Contact email
Sponsor organisation
Oragenics, Inc.
Eudract number
2016-004161-68
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 18 days
Research summary
This is a Phase 2 international study investigating an experimental drug called AG013 in the treatment of patients with oral mucositis compared to placebo when administered three times per day. AG013 will be administered to subjects with cancers of the head and neck receiving concomitant chemoradiation (CRT) therapy.
This is a double-blind study, which means that neither the participants nor the study doctor will know the treatment group they will be in. The participants will have one chance out of two of them receiving AG013.
AG013 is a rinse that contains genetically modified bacteria called Lactococcus lactis (L. lactis). To make AG013, the genetic material (DNA) of L. lactis has been changed in the laboratory so the bacteria act as miniature factories to secrete a protein called human Trefoil Factor 1 (hTFF1). hTFF1 is normally secreted by saliva and intestines, but when used as a rinse, the genetically-modified bacteria (AG013) produce additional hTFF1 which may help resist mucositis during cancer treatment.
There are 4 study periods: screening, active treatment, short term follow-up and long term follow-up. The screening phase will be no longer than 4 weeks. The active treatment phase will be between 7 and 9 weeks depending on the participants prescribed CRT plan. The short term follow-up phase will be 4 weeks in duration. The long term follow-up will continue until 12 months post CRT. Oral mucositis (OM) assessments will begin at the start of CRT and continue until the participant has completed short term follow-up or until the OM resolves, whichever comes first. Long term follow-up will continue for 12 months to assure that AG013 does not adversely impact the tumour response to antineoplastic therapy.About 200 participants are planned to take part in the study. The study is sponsored by Oragenics Inc.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1222
Date of REC Opinion
4 Dec 2018
REC opinion
Further Information Favourable Opinion