DIR 192

Clinical trial of a genetically modified (GM) chimeric Orthopoxvirus (CF33-hNIS) as a cancer treatment

Licence details

Licence number:
DIR 192
Licence status:
Limited and controlled

Medpace Australia Pty Ltd

Parent organism:

Chimeric orthopoxvirus CF33

Modified trait:

Human therapeutic

Licence issue date:

This licence authorises Medpace Australia Pty Ltd to conduct a clinical trial of a genetically modified (GM) chimeric orthopoxvirus as a cancer treatment in Australia.

The genetically modified organism (GMO) is genetically similar to the vaccinia virus used as a vaccine during the global smallpox eradication campaign. It has been modified by deletion of a gene so that it preferentially multiplies in and kills cancer cells. Additionally, a gene derived from humans has been introduced to facilitate the visualisation of the GMO after administration to patients by medical imaging.

The GMO will be manufactured overseas and imported into Australia. Up to 18 trial participants will receive multiple doses of the GMO over a period of 2 years.

The Risk Assessment and Risk Management Plan (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:

  • limit the duration and location of the trial
  • 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:


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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