Licence details
Western Sydney Local Health District (WSLHD)
Bacteriophage
Render the bacteriophage lytic
This licence allows Western Sydney Local Health District to conduct a clinical trial of a genetically modified (GM) bacteriophage treatment for the treatment of mycobacterial infections in Australia.
The aim of the clinical trial is to gather data to assess the effectiveness of the GM bacteriophage treatment both in hospitals and under Hospital-in-the-Home programs, administered by endobronchial lavage, nebuliser, intravenous injection, direct instillation, and topical application. It is hoped that this GM bacteriophage treatment offers an option to patients with multi-drug resistant mycobacterial infections, where standard measures either do not exist or are no longer effective. Once bacteriophages infect a bacterial cell, they typically either live inside the bacterial cell, or reproduce and kill the cell. The GM bacteriophages have been modified to remove the ability to live in bacteria, so they can only reproduce in the bacteria and destroy the infection.
Participants are eligible under the Special Access Scheme categories A and/or B. At least 3 participants will take part in the trial over 5 years.
The GM bacteriophages will be imported and transported directly to clinical trial sites.
The RARMP concluded that the clinical trial poses negligible risks to people or the environment. However, as this is a clinical trial under limited and controlled conditions, licence conditions have been imposed to:
- restrict when and where the trial can take place
- restrict the type of participant able to be enrolled in the trial as those eligible under the Special access scheme category A or B
- restrict the spread and persistence of the GM bacteriophages.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Documents
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.
Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.