GMO dealings

DIR 222

Clinical trial of genetically modified adenovirus for the treatment of locally advanced rectal cancer

Licence details

Licence number:
DIR 222
Licence status:
Current
Category:
Medical
Release:
Limited and controlled
Organisation:

Novotech (Australia) Pty Ltd

Parent organism:

Human Adenovirus

Modified trait:

Human therapeutic - expression of agonist antibody to human CD40

Licence issue date:
Description:

This licence allows Novotech (Australia) Pty Ltd to conduct a clinical trial of a genetically modified (GM) adenovirus for the treatment of locally advanced rectal cancer in Australia.

The GM treatment is based on a non-GM adenovirus which lacks several genes, making it infect and preferentially multiply in cancer cells. This non-GM adenovirus has been used in clinical trials to treat different cancers in people. The GMO has been produced by modifying the non-GM adenovirus by inserting two genes encoding for one protein that stimulates the body’s immune system to recognise and kill tumour cells. 

The GMO will be manufactured overseas and imported into Australia. Up to 40 patients with locally advanced rectal cancer will receive the GMO at clinical trial sites and hospitals in Australia.

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
  • limit the size of the trial
  • restrict the spread and persistence of the GMO.

The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.

Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:

Documents

Licence decision - notification

Outlines the Regulator’s decision to issue a licence following the assessment of this application.

Licence decision - Q&A

FAQs on the licence application and the Regulator’s decision to issue a licence for this application.

Risk assessment and risk management plan - summary

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.

Risk assessment and risk management plan - full version

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.

Licence conditions

Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.

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