Invitation to comment on a clinical trial of a genetically modified alphavirus (Getah virus) for cancer treatment

The Gene Technology Regulator is assessing an application from VRT Pharmaceutics Pty Ltd to conduct a clinical trial, under limited and controlled conditions, of a genetically modified Getah virus for the treatment of cancer. The trial is proposed to take place at clinical trial sites in South Australia. Up to 12 trial participants would be treated over a five-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 198), or from the contacts below. Submissions should reference DIR 198 and be received by 05 October 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