Final-stage clinical trials of a cervical cancer vaccinedeveloped by University of Queensland (UQ) scientists, have shown thedrug to be 100 per cent effective.
The results of the Phase IIItrials were announced overnight in New York by internationalpharmaceutical company Merck & Co. who are developing the product.
Itwas the pioneering research work of Professor Ian Frazer from UQ'sCentre for Immunology and Cancer Research (CICR) that led to thedevelopment of the vaccine.
Professor Frazer said he was delighted by the news and pleased to have been involved in the vaccine's creation.
“Itis very rare, almost unheard of, to achieve a 100% efficacy rate in anytreatment, so these results are truly wonderful,” he said.
“It isthe first time in the world that a vaccine designed to prevent cancerhas been developed, and it has happened right here in Australia.
“Itis very encouraging to see such great results coming out of Australianresearch, and developed in conjunction with Australian company CSL, andinternational pharmaceutical company Merck & Co.
“It is sad that Dr Jian Zhou, who was my research partner, passed away before the work was publicly recognised.”
Thevaccine is called Gardasil™ and it is expected to be submitted forapproval by the United States Food and Drug Administration (FDA) withinthe next two months.
If the drug is approved by the FDA asanticipated by the international scientific community, the vaccineshould be commercially available in early 2006.
The trial is partof the ongoing phase III program for Gardasil™, which has involved morethan 25,000 people in 33 countries worldwide in total.
Women aged16 years to 26 years were chosen at random to receive a three-doseregimen 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-gradepre-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.
Noneof the women involved in the trial were forced to pull out as a resultof adverse side-affects. The most serious adverse side-affect reportedwas 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.
HPVstrain types 16 and 18 lead to the development of cervical cancer, adisease 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.
Othertypes of the HPV virus cause genital and skin warts. The HPV`s thatconvey a high risk of cervical cancer are contracted by up to anestimated 70 per cent of sexually active women.
Professor Frazersaid Gardasil™ would only protect women who were not infected with HPV,but he hoped to change this in the future.
“My major focus thesedays, as indeed it was right back in the beginning, is on developing avaccine 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.”
ProfessorFrazer hails from Scotland and trained as a renal physician andclinical immunologist in Edinburgh before immigrating to Australia in1980.
In addition to his responsibilities as Head of CICR, he isthe director of a biotechnology start up company, Coridon, which has aninterest in optimising and targeting polynucle vaccine proteinexpression.
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