Oct. 12, 2005 Final-stage clinical trials of a cervical cancer vaccine developed by University of Queensland (UQ) scientists, have shown the drug to be 100 per cent effective.
The results of the Phase III trials were announced overnight in New York by international pharmaceutical company Merck & Co. who are developing the product.
It was the pioneering research work of Professor Ian Frazer from UQ's Centre for Immunology and Cancer Research (CICR) that led to the development of the vaccine.
Professor Frazer said he was delighted by the news and pleased to have been involved in the vaccine's creation.
“It is very rare, almost unheard of, to achieve a 100% efficacy rate in any treatment, so these results are truly wonderful,” he said.
“It is the first time in the world that a vaccine designed to prevent cancer has been developed, and it has happened right here in Australia.
“It is very encouraging to see such great results coming out of Australian research, and developed in conjunction with Australian company CSL, and international pharmaceutical company Merck & Co.
“It is sad that Dr Jian Zhou, who was my research partner, passed away before the work was publicly recognised.”
The vaccine is called Gardasil™ and it is expected to be submitted for approval by the United States Food and Drug Administration (FDA) within the next two months.
If the drug is approved by the FDA as anticipated by the international scientific community, the vaccine should be commercially available in early 2006.
The trial is part of the ongoing phase III program for Gardasil™, which has involved more than 25,000 people in 33 countries worldwide in total.
Women aged 16 years to 26 years were chosen at random to receive a three-dose regimen of either Gardasil™ or placebo at Day 1, Month 2, and Month 6.
Gardasil™ was successful in preventing 100 per cent of cases of high-grade pre-cancer and non-invasive cancer associated with human papillomavirus (HPV) strains Type 16 and 18, which cause cervical cancer.
These clinical trial results mirror the outcomes of earlier stage tests also carried out by Merck & Co.
None of the women involved in the trial were forced to pull out as a result of adverse side-affects. The most serious adverse side-affect reported was local discomfort at the injection site.
Cervical cancer is one of the few human cancers that is known to be directly caused by a viral infection.
HPV strain types 16 and 18 lead to the development of cervical cancer, a disease that is the second leading cause of cancer amongst women.
More than 500,000 cases are diagnosed annually and it kills an estimated 275,000 women around the world every year.
Other types of the HPV virus cause genital and skin warts. The HPV`s that convey a high risk of cervical cancer are contracted by up to an estimated 70 per cent of sexually active women.
Professor Frazer said Gardasil™ would only protect women who were not infected with HPV, but he hoped to change this in the future.
“My major focus these days, as indeed it was right back in the beginning, is on developing a vaccine to treat these existing infections,” he said.
“We have produced a second vaccine which we hope will do this, however clinical trials are still at a very early stage.
“A therapeutic vaccine to treat already infected individuals is much harder to develop than a vaccine to prevent infection.”
Professor Frazer hails from Scotland and trained as a renal physician and clinical immunologist in Edinburgh before immigrating to Australia in 1980.
In addition to his responsibilities as Head of CICR, he is
the director of a biotechnology start up company, Coridon, which has an
interest in optimising and targeting polynucle vaccine protein
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