Novotech (Australia) Pty Ltd
This licence allows Novotech (Australia) Pty Ltd to conduct a clinical trial of bacteria genetically modified (GM) for treatment of inflammatory bowel disease.
The GM treatment is based on Lactobacillus brevis bacteria, which are sometimes used in probiotics. The GMO has been modified by introduction of a gene encoding a human peptide that signals the immune system to reduce inflammation.
The GMO will be imported into Australia. Up to 28 healthy trial participants will be treated with the GMO. The treatment will be taken at medical facilities or at the trial participants’ homes, in Melbourne, Victoria.
The Risk Assessment and Risk Management Plan (RARMP) for this application concludes that the clinical trial poses negligible to moderate risks to people or the environment. Licence conditions have been imposed to manage these risks.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.
The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.