24 July 2023

Invitation to comment on a clinical trial of genetically modified Lactobacillus brevis bacteria

The Gene Technology Regulator is assessing an application from Novotech (Australia) Pty Ltd to conduct a clinical trial of genetically modified Lactobacillus brevis bacteria for treatment of inflammatory bowel disease. The trial is proposed to take place at medical facilities and the homes of clinical trial participants. Up to 60 trial participants would be treated over a period of 7 years.

The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and welcomes written submissions relating to the protection of human health and safety and the environment prior to making a decision on whether to issue the licence.

The consultation RARMP and related information can be obtained via our website (search for DIR 197), or from the contacts below. Submissions should reference DIR 197 and be received by 25 August 2023.

Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601

Telephone: 1800 181 030   Website: www.ogtr.gov.au

E-mail: ogtr@health.gov.au