13 December 2024

Invitation to comment on a clinical trial of a genetically modified vaccinia virus for the treatment of solid tumours (DIR 208)

The Gene Technology Regulator is assessing an application from Novotech (Australia) Pty Ltd to conduct a clinical trial of a genetically modified (GM) vaccinia virus for the treatment of solid tumours. The trial is proposed to take place at clinical trial sites and hospitals in Australia. Up to 40 trial participants would be treated over a 5 year period.

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 208), or from the contacts below. Submissions should reference DIR 208 and be received by 30 January 2025.

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