The U.S. Food and Drug Administration has approved phase one human clinical trials in the United States of a genital warts HPV11 prophylactic vaccine developed at the University of Queensland.
The trials, to be conducted by pharmaceutical company Merck and Co. Inc., will use a vaccine based on virus-like particles to prevent Human Papillomavirus (HPV) infection, the cause of genital warts and cervical cancer.
The trials are an important milestone in bringing the vaccine to the world-wide marketplace, and also achieving commercialisation reward for the University, according to Janet Caffin, General Manager (Life Sciences) at UniQuest Limited, the University's technology transfer company.
The vaccine was developed by a world-class team of University researchers led by Professor Ian Frazer at the University's 43-scientist Centre for Immunology and Cancer Research (CICR), University's Department of Medicine, Princess Alexandra Hospital, Brisbane.
'Although this work has now been licensed to CSL Limited and Merck and Co., as a commercial sponsor is required to get such a vaccine into the clinic, we naturally take a great interest in its progress,' Professor Frazer said.
Until now there has been no vaccine available to prevent or treat diseases caused by Human Papillomaviruses (HPV).
The partners in the collaborative project believe the work could bring benefits to millions of people in many countries, especially women who are at risk of developing cervical cancer after HPV infection. HPV affects one in three people sometime in their lives. Many people are unaware they have been infected.
Professor Frazer said 50 to 60 percent of sexually active people acquired the infection, which was difficult to eradicate and was also linked to genital tract cancer.
'The virus is good at evading the immune system and normal defences against infection,' he said.
In the past 12 years the University of Queensland team has developed a number of approaches to the management of HPV infection and associated conditions.
Researchers identified and patented a technology which could lead to an effective vaccine to prevent HPV, the cause of genital warts and cervical cancer. This or a modified product may be useful for the treatment of genital warts.
Professor Frazer said virus-like particles (VLPs), first produced by Dr Jian Zhou at the CICR were genetically engineered to imitate the protein particle of the HPV virus. The particle is similar enough to the real virus to stimulate an immune response. However, it does not have the genes of the virus and so cannot produce the diseases of warts or cervical cancer.
The immunity triggered by these particles in animals has so far protected them against developing disease. Researchers hope that similar protection will be provided by the vaccine when it is tested in humans, as part of the current agreement with CSL Limited and Merck.
In 1995 following a year of negotiations, major agreements were signed involving UniQuest; Melbourne-based pharmaceutical biological and veterinary manufacturer CSL Limited; and the vaccine division of Merck and Co. Inc., of New Jersey, United States, the world's largest pharmaceutical company.
CSL has an agreement with UniQuest which provides CSL with exclusive worldwide rights to commercialise the products of the collaboration. CSL has exclusively licensed its world-wide rights to Merck while retaining marketing rights for Australia and New Zealand.
The world-class research team which developed the virus-like particle technology was spearheaded by Dr Robert Tindle (now Deputy Director of the Sir Albert Sakzewski Virus Research Centre) and Dr Germain Fernando.
Professor Frazer said the researchers had a competitive edge in an international scientific war against HPV. Medical research teams in Cardiff, Wales, and Leyden, Netherlands, and Maryland, USA, are using different scientific approaches against the virus. However, Professor Frazer's team is believed to be the first to develop an approach to the development of a vaccine using virus-like particles.
In addition to the CSL funding, the University of Queensland team has received almost $1.4 million funding from the National Cancer Institute of the United States National Institutes of Health in Maryland, since 1992.
Their work is also being supported by groups including the National Health and Medical Research Foundation, the Australian Research Council, Queensland Cancer Fund, the University of Queensland, Princess Alexandra Hospital, and the Lions Kidney and Medical Research Foundation.
Professor Frazer said one scientific highlight in the past year for the research team had been the identification by Dr Magnus Evander and Dr Nigel McMillan of a candidate Papillomavirus receptor. This discovery would allow rapid progress in understanding of the biology of HPV infection.
He said clinical trials of immunotherapy for genital warts, cervical cancer, melanoma and lymphoma continued in Brisbane in conjunction with clinical collaborators at the Princess Alexandra Hospital and elsewhere.
'A transgenic mouse model in which Papillomavirus proteins are expressed in the skin, has proven very informative for our cervical cancer work,' he said.
'Through this model we are gaining insight into the means by which the immune system can control the growth of viruses within the skin. Our collaboration with Dr Paul Lambert from Madison, Wisconsin at the McArdle Cancer Institute continues to prove fruitful in this area.'
Janet Caffin said UniQuest's business was to forge research business partnerships between research groups such as the outstanding group led by Professor Frazer, and large, resourceful commercial organisations such as CSL and Merck.
'In the case of products like the HPV vaccine, the only way that the creative and dedicated effort of the scientists can find its way to bring life-giving benefits to the world's population is by commercialisation,' she said.
For further information, contact Professor Frazer, telephone 07 3240 5315 or Ms Caffin, telephone 07 3365 4037.
