OGTR to review application for GM trial


The Office of the Gene Technology Regulator (OGTR) has confirmed that it has received a licence application from Clinical Network Services (CNS) to conduct a Phase 3 clinical trial of a genetically modified (GM) virus for the treatment of liver cancer.

CNS is an integrated service group focused on product development headquartered in Australia with offices in New Zealand, the UK and the US.

CNS offers a unique service where it integrates BioDesk, an intelligent global product development and regulatory affairs consultancy, with a highly experienced Australian/New Zealand clinical operations and biometrics team.

According to the OGTR, CNS proposes that the GM virus (known as Pexa-Vec) be administered to up to 50 adult volunteers with advanced liver cancer, in conjunction with a standard cancer treatment.

The GM would be injected directly into tumours by trained medical staff.

Trial sites are yet to be finalised, but hospitals throughout Australia may be involved.

If approved, CNS said it expects the trial to be completed within one year of patient enrolment but has requested a period of up to 5 years to allow for any follow-up studies that may be required.

The applicant has proposed a number of control measures to restrict the spread and persistence of the GMO and its introduced genetic material.

OGTR said it is preparing a comprehensive 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 December 2015. There will be at least 30 days for submission of comments.