DIR 223 Clinical trial of a genetically modified adenovirus for treatment of bladder cancer

Between 23 January and 6 March 2026, we sought your feedback on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) prepared for the DIR 223 licence application (clinical trials of a genetically modified adenovirus for the treatment of bladder cancer from Ferring Pharmaceuticals Pty Ltd).

During the 6-week consultation period, we received advice from prescribed Government agencies, Local Government Areas and the Gene Technology Technical Advisory Committee. No submissions were received from the public.

We heard support for:

• the proposed limits and controls listed in the RARMP
• the overall conclusions of the RARMP.

We also heard concerns for exposure of people following shedding of the genetically modified adenovirus from clinical trial participants into the environment.

We analysed the feedback provided during the public consultation process in finalising the RARMP. The issues raised and how they were addressed can be found in Appendix A of the final RARMP.

The Gene Technology Regulator issued a licence to Ferring Pharmaceuticals Pty Ltd for clinical trials with a GM adenovirus on 10 April 2026. More details, including the final version of the RARMP and the licence, are available at DIR 223 | Office of the Gene Technology Regulator.

We appreciate all those who provided input to the consultation – your feedback will help to ensure that any risks posed by gene technology to people and the environment continue to be managed.