Published on Monday, 6 January 2025 at 3:51:15 PM
The Office of the Gene Technology Regulator (OGTR) has received a licence application (DIR 213) from Novotech Australia Pty Ltd to conduct a clinical trial of genetically modified (GM) human adenovirus for treatment of melanoma. A summary of the application is posted on their website.
The clinical trial is proposed to take place at hospitals and clinics within Australia over a period of 3 years. Up to 30 patients in Australia would receive up to 7 doses of the GM treatment over a period of 3 months, with the aim to evaluate the treatment’s safety and efficacy.
The OGTR is preparing a Risk Assessment and Risk Management Plan for the application. This is expected to be released for public comment and advice from experts, agencies and authorities in early March 2025. There will be at least 30 days for submission of comments.
If you have any questions or would like to receive a copy of the application or the summary, please contact the OGTR and quote the reference number DIR 213.
Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 E-mail: ogtr@health.gov.au
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