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EPA approves use of virus for liver cancer treatment trial

29 October 2015

EPA approves use of virus for liver cancer treatment trial

The Environmental Protection Authority (EPA) has approved an application to import for release a genetically modified live vaccinia virus (Pexa-Vec) for use in a multi-national clinical trial involving patients with a form of liver cancer (hepatocellular carcinoma).

The applicant, SillaJen Biotherapeutics Inc, intends to carry out a Phase 3 clinical trial of Pexa-Vec treatment in New Zealand.

Pexa-Vec is a weakened (or attenuated) virus that is based on a vaccine used in the eradication of smallpox. The modified virus is injected directly into the cancer tumour, to grow inside these rapidly growing cancer cells and kill them.

More than 300 overseas patients with advanced cancers have received Pexa-Vec treatments in previous clinical trials. There are approximately 180 new cases of liver cancer in New Zealand each year.

Approval for the clinical trial will also be needed from Medsafe, which includes consideration by a committee of the Health Research Council and an ethics committee, before it can be used in New Zealand.

The EPA made the decision to approve the importation for release of Pexa-Vec after conducting a thorough assessment of the potential risks to the health and safety of the public, any valued species, natural habitats or the environment, said General Manager Applications and Assessments Sarah Gardner. A number of controls have been put in place to manage the risks to people and the environment.

The controls include restrictions on who can receive the virus, how it is administered, education of trial participants, provision and collection of biohazard containers for waste, and reporting and notification requirements.

In its application, the company said that data from previous clinical trials supported Pexa-Vec as a promising therapy against liver cancer. Potential immediate benefits included tumour shrinkage, alleviation of cancer symptoms and improved quality of life, cancer remission and prolonged survival.

In a Phase 3 clinical trial, a drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Pexa-Vec will be administered to patients with hepatocellular carcinoma who are enrolled in the Phase 3 clinical trial programme. These trials will assess the effectiveness and side effects of the virus and compare it to other available treatments. Pexa-Vec treatment will be followed by the standard liver cancer treatment sorafenib.

If also approved by Medsafe, storage, preparation and administration of Pexa-Vec will potentially occur within public hospitals and clinical settings in New Zealand. Samples from Pexa-Vec treated patients will be analysed to monitor patient safety during the clinical study.

Pexa-Vec virus is the first genetically modified organism for human therapeutic purpose that is capable of reproducing itself to be approved by the EPA for release under the HSNO Act.

The application was approved under section 38I of the HSNO Act, which provides for a rapid assessment of applications received under section 34, if the application seeks the release of a qualifying organism. A qualifying organism is, in part, a new organism (including a genetically modified organism) that is or is contained in a medicine.

Read more about this application and the decision on the EPA website

The EPA’s role is to ensure new organisms can be imported without harming our environment. We put controls in place to manage the risk of new organisms to safeguard people and the environment.


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