Executive Summary Introduction




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Risk Assessment and

Risk Management Plan for

DIR 116


Consultation Version


Limited and controlled release of genetically modified live viral vaccines against prostate cancer


Applicant: PPD Australia Pty Ltd


July 2012


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Executive Summary

Introduction


A licence application (DIR 116) has been received from PPD Australia Pty Ltd (PPD) for a limited and controlled release of genetically modified (GM) live viral vaccines against prostate cancer.

The Gene Technology Act 2000 (the Act), the Gene Technology Regulations 2001 and corresponding state and territory law govern the comprehensive and highly consultative process undertaken by Gene Technology Regulator (the Regulator) before making a decision whether to issue a licence to deal with a genetically modified organism (GMO).

In accordance with the gene technology legislation, a detailed Risk Assessment and Risk Management Plan (RARMP) for the dealings proposed by the applicant has been prepared for consultation. The Regulator now invites submissions in order to finalise the document, which will then form the basis of his decision whether to issue a licence1.

The application


PPD have applied for a licence for an intentional release of two genetically modified (GM) vaccines for the treatment of prostate cancer into the Australian environment on a limited scale and under controlled conditions.

The GM candidate vaccines are based on Vaccinia virus vaccine strain New York City Board of Health (NYCBH) and Fowlpox virus vaccine strain POXVAC-TC which have each been modified to contain the same four human genes. Expression of these genes is expected to induce immune responses against the prostate-specific antigen (PSA) and to stimulate the immune system to attack and destroy cancer cells expressing PSA.

This proposed trial in Australia would form part of an international clinical trial involving 1200 patients in approximately 22 countries. The purpose of the trial is to evaluate the effectiveness of the viral vaccines in treating prostate cancer. The trial is proposed to take place in specified hospitals and health care facilities in ACT, NSW, QLD, SA, VIC and WA. Once underway the trial is expected to be completed within five years.

The applicant has proposed a number of control measures to restrict exposure to the GM vaccines that will be considered during the evaluation of this application.

Confidential Commercial Information


Some information, including details of the genetic construct used to create the GMOs and unpublished data from previous clinical have been declared Confidential Commercial Information (CCI) under section 185 of the Act. The confidential information will be made available to the prescribed experts and agencies that will be consulted on the RARMP for this application.

Risk assessment

The risk assessment takes into account information in the application (including proposed containment measures), relevant previous approvals and current scientific knowledge.

Initially, potential pathways that might lead to harm to people or the environment as a result of gene technology are postulated (risk scenarios), and those that warrant detailed characterisation are determined. This process is described as risk identification.

Seven risk scenarios were postulated, including consideration of whether or not expression of the introduced genes could result in products that are toxic or allergenic to people or other organisms; alter characteristics that may impact on the disease burden due to the GM viruses; or produce unintended changes in viral characteristics. The opportunity for gene flow to other organisms, and its effects if it were to occur, was also assessed.

A risk is only identified for further assessment when a risk scenario is considered to have some chance of causing harm. Pathways that do not lead to an adverse outcome, or could not reasonably occur, do not advance in the risk assessment process.

The characterisation of the seven risk scenarios in relation to both the seriousness and likelihood of harm, in the context of the control measures proposed by the applicant and considering both the short and the long term, did not give rise to any identified risks that required further assessment.

Any risks of harm to the health and safety of people, or the environment, from the proposed release of the GM viruses into the environment are assessed to be negligible. Hence, the Regulator considers that the dealings involved in this limited and controlled release do not pose a significant risk to either people or the environment2.
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