Licence details
Novotech (Australia) Pty Ltd
Vaccinia virus
Human therapeutic- attenuation, enhanced immune response. Reporter gene expression.
This licence allows Novotech (Australia) Pty Ltd to conduct a clinical trial of a genetically modified virus for treatment of liver, kidney and prostate cancer. The GM virus will be administered to adult volunteers with advanced HCC. It will be
injected directly into tumours of 600 patients by trained medical staff in hospitals that offer specialised cancer treatment services.Clinical trials in Australia are also overseen by the Therapeutic Goods Administration (TGA) and so Novotech will also need approval from TGA before the trial can start.
The purpose of the trial is to assess the effectiveness and safety of the GM virus as a treatment for Hepatocellular Carcinoma (HCC), a common type of liver cancer, when provided in conjunction with a standard treatment. Control measures include administration of the GM virus by trained medical staff only, exclusion of individuals at risk of adverse effects from the trial, educating trial volunteers about measures to prevent transmission of the GM virus, and appropriate disposal of all trial waste. Clinical trials in Australia must also follow the National Statement on Ethical Conduct in Human Research and the Guidelines for Good Clinical Practice of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Novotech will also need permission from the Department of Agriculture, Water and the Environment to import the GM vaccine.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework
Documents
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
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.
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.
Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.