Clinical trials are on track to begin towards the end of September 2008 once manufacturing and regulatory requirements have been completed. The main infrastructure will be provided through Griffiths University located on the Gold Coast in Queensland. As well as Dr Ralph, Dr Mark Smithers (Princess Alexandra Hospital/Brisbane) has been recruited to assist in the trials. Both have had extensive experience in clinical melanoma trials and have access to large numbers of patients with stage II/III/IV melanoma.
After lengthy deliberation and new modified protocols being put forward, human ethics approval has been received for the clinical trials. The trials will take place at the Princess Alexandra Hospital Melanoma Unit, Wooloongabba, Queensland. Griffith University also has approval to test the immune response of patients to the vaccine at the Genvax laboratory. This latter approval will assist the project immensely as the transport time between the two facilities will be kept to a bare minimum greatly enhancing the efficiency of the process. The immune response assay will utilise a gene vector expressing a fluorescent protein fused in frame to a luciferase enzyme. This vector will be transfected into the vaccine cancer cell lines and other cell lines that will be used as target indicators for immune mediated cell killing by patient’s blood derived lymphocytes. It will serve as a highly sensitive assay for detecting changes in patient immune response after vaccination.
The TGA has been notified and the trial has been registered as a CTN (Clinical Trial Notification). To comply with TGA/FDA requirements Clinical Network Services based in Brisbane has been contracted to monitor the trial proceedings. This group will also assist with ensuring the trial complies with TGA/FDA requirements and prepare outcome reporting analysis.
The vaccine manufacturer, Cell Therapies located at the Peter MacCallum Cancer Institute (Melbourne), have completed a dummy run of production in line with SOP’s (Standard Operating Procedures) being a cGMP facility. The cell lines have undergone extensive testing and passed all tests emphatically. The Master Cell Banking has also been finalised. Vaccine production commences in September ‘08 . | 
