Aussie cure for cervical cancer

By Adam Cresswell
October 08, 2005

AN Australian scientist has developed the world's first cancer vaccine - a drug with the potential to save the lives of tens of thousands of women each year by preventing cervical cancer.

The vaccine - based on work started 15 years ago by Ian Frazer, director of the Centre for Immunology and Cancer Research at the University of Queensland - received a huge boost yesterday when researchers reported a 100 per cent success rate in final trials.
The results mean it could be on sale in Australia by the end of next year, after its developer, Melbourne drugmaker CSL, revealed the trial found it gave recipients 100 per cent protection against two strains of human papillomavirus, or HPV.

Together, the two strains cause about 70 per cent of cervical cancers.

The success rate has surprised and delighted Australian and overseas experts, who say the vaccine could potentially save 70 per cent of the 250,000 lives lost each year around the world to cervical cancer - especially in developing countries that lack pap-smear screening programs.

Australia has about 700 cases of cervical cancer diagnosed every year, and about 270 deaths from the disease.

The Phase III trial - the last step before a licensing application - involved 12,000 women in 13 countries.

It found the vaccine prevented all high-grade cervical pre-cancers and non-invasive cervical cancers associated with HPV types 16 and 18.

Already CSL is looking at a financial bonanza from the vaccine, to be called Gardasil, which is thought likely to generate worldwide sales of between $US1billion ($1.3 billion) and $US4billion.

Another winner will be Professor Frazer, whose invention made the vaccine possible, with some peers suggesting he could be in line for a Nobel Prize.

Fourteen years ago, Professor Frazer and his team used genetic engineering to unlock the secret of how to produce in sufficient quantities fragments of the HPV virus.

The dead fragments, called "virus-like particles", are put into the vaccine and trick the immune system into thinking the virus itself is present. The body responds by making antibodies that then protect the patient if the real virus later appears.

Gerry Wain, a cervical cancer specialist at Sydney's Westmead Hospital and director of the NSW Cervical Screening Program, who was not involved in the vaccine's development, said the results were "amazing" and had exceeded all expectations.

"You are looking at saving millions of women's lives - if that doesn't deserve a Nobel prize, what does?" he said.

Gardasil is designed to be given in three doses over six months, which data suggests will provide immunity for at least 10 years.

Most women who develop cervical cancer acquire the HPV virus in the first 10 years after they become sexually active. However, a booster shot to extend immunity beyond the initial 10 years may later be recommended.

The vaccine is designed to be given before women become sexually active, but it could still bring benefits for older women.

Even men could benefit, as it protects against two other types of HPV responsible for genital warts.

Professor Frazer told The Weekend Australian from New York yesterday he was "obviously delighted and surprised by the 100 per cent effectiveness".

"With most vaccines, you think you're doing a pretty good job if the vaccine turns out to be 90 per cent effective," he said.

"It's great for Australian science that something that we've developed here is going to have a global impact in the way that this vaccine should have."

He said the vaccine would have the biggest impact in developing countries that did not have pap-smear screening programs.

"In countries like Australia, where we have a very good pap-smear program, the good news for women is not so much that they will be able to stop doing the pap smears - because they won't - but rather that they are very much less likely to have an abnormal pap smear which will need something done about it."

CSL will market the vaccine in Australia and New Zealand but will receive royalties for overseas sales from its international distributor, the drug giant Merck.

It is thought royalties will be worth tens of millions of dollars a year to CSL.

CSL shares soared yesterday to a high of $38.80 before closing at $37.46, up 96c, giving the company a market value of $6.8 billion. A rival vaccine, Cervarix, is being developed by drug giant GlaxoSmithKline and is likely to become available shortly after Gardasil.

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Cervical cancer vaccine 'available within a year'
By Geneviève Roberts
Published: 07 October 2005
A vaccine to prevent cervical cancer could be available to women in Britain within a year.

A pharmaceutical firm has trialled a new drug, Gardasil, which has proved 100 per cent effective in blocking a major cause of cervical cancer, which kills 1,500 women in Britain every year.

The dramatic results of the trial have been described as "stunning" and "exciting" by Professor Margaret Stanley, an expert in the human papilloma virus (HPV) at Cambridge University. Gardasil is designed to protect against two strains of the virus, which trigger 70 per cent of cervical cancers.

The vaccine not only acts against the HPV 16 and 18 strains, but also against the strains six and 11, which cause genital warts.

Cervical cancer kills 274,000 women worldwide every year - and is the second most prevalent form of cancer in women in their twenties, thirties and forties. Women are encouraged to have smear tests every three years for warning signs that the cancer is developing. HPV is sexually transmitted and carried by 15 per cent of women in their thirties. Although teenagers and adults took part in the trials, the vaccine is likely to be administered to girls as young as 10 to 13 who are free of the virus.

A total of 12,167 women aged 16 to 23 from 13 countries, including the UK, took part. Half were given three injections of Gardasil spanning six months and half jabs of an inactive dummy drug. They were then monitored for an average of two years. None of the women were infected with HPV at the start of the trial and they remained infection free throughout treatment.

Similar results were seen in a smaller trial of 277 women. The new study, Future II, is part of a phase III trial programme involving more than 25,000 patients in 33 countries.

Professor Stanley said: "We now have evidence that Gardasil is effective against the advanced-stage abnormalities of the cervix, called lesions, that lead to invasive cervical cancer.

"The smaller-scale preliminary HPV vaccine trials published to date have only indicated that this may be the case, but this study gives us very solid evidence. The results of Future II are so exciting because of the sheer size of the trial and the fact that it demonstrated 100 per cent efficacy."

Some critics have argued that administering a vaccine against a sexually transmitted disease on children so young is encouraging underage sex, but with 15,000 a year in Europe dying from the disease, the vaccine is likelyto be widely welcomed.

Gardasil's manufacturers are on track to apply for a US Food and Drug Administration licence to market the vaccine before the end of this year. This will be followed by a licence application to the European Medicines Agency.

The vaccine is a joint venture by the pharmaceutical companies Sanofi Pasteur and Merck. It is in competition with another HPV vaccine from GlaxoSmithKline called Cervarix, which is also undergoing trials. The vaccines could be among the biggest-selling drugs of all time. One analyst has estimated that Gardasil could be worth $1bn (£570m) a year.

Professor Peter Rigby, the chief executive of the Institute of Cancer research, said: "These results are extremely encouraging.

"It is exciting to hear that it may be possible to dramatically reduce the number of people diagnosed with cervical cancer in the forseeable future."

A vaccine to prevent cervical cancer could be available to women in Britain within a year.

A pharmaceutical firm has trialled a new drug, Gardasil, which has proved 100 per cent effective in blocking a major cause of cervical cancer, which kills 1,500 women in Britain every year.

The dramatic results of the trial have been described as "stunning" and "exciting" by Professor Margaret Stanley, an expert in the human papilloma virus (HPV) at Cambridge University. Gardasil is designed to protect against two strains of the virus, which trigger 70 per cent of cervical cancers.

The vaccine not only acts against the HPV 16 and 18 strains, but also against the strains six and 11, which cause genital warts.

Cervical cancer kills 274,000 women worldwide every year - and is the second most prevalent form of cancer in women in their twenties, thirties and forties. Women are encouraged to have smear tests every three years for warning signs that the cancer is developing. HPV is sexually transmitted and carried by 15 per cent of women in their thirties. Although teenagers and adults took part in the trials, the vaccine is likely to be administered to girls as young as 10 to 13 who are free of the virus.

A total of 12,167 women aged 16 to 23 from 13 countries, including the UK, took part. Half were given three injections of Gardasil spanning six months and half jabs of an inactive dummy drug. They were then monitored for an average of two years. None of the women were infected with HPV at the start of the trial and they remained infection free throughout treatment.

Similar results were seen in a smaller trial of 277 women. The new study, Future II, is part of a phase III trial programme involving more than 25,000 patients in 33 countries.
Professor Stanley said: "We now have evidence that Gardasil is effective against the advanced-stage abnormalities of the cervix, called lesions, that lead to invasive cervical cancer.

"The smaller-scale preliminary HPV vaccine trials published to date have only indicated that this may be the case, but this study gives us very solid evidence. The results of Future II are so exciting because of the sheer size of the trial and the fact that it demonstrated 100 per cent efficacy."

Some critics have argued that administering a vaccine against a sexually transmitted disease on children so young is encouraging underage sex, but with 15,000 a year in Europe dying from the disease, the vaccine is likelyto be widely welcomed.

Gardasil's manufacturers are on track to apply for a US Food and Drug Administration licence to market the vaccine before the end of this year. This will be followed by a licence application to the European Medicines Agency.

The vaccine is a joint venture by the pharmaceutical companies Sanofi Pasteur and Merck. It is in competition with another HPV vaccine from GlaxoSmithKline called Cervarix, which is also undergoing trials. The vaccines could be among the biggest-selling drugs of all time. One analyst has estimated that Gardasil could be worth $1bn (£570m) a year.

Professor Peter Rigby, the chief executive of the Institute of Cancer research, said: "These results are extremely encouraging.

"It is exciting to hear that it may be possible to dramatically reduce the number of people diagnosed with cervical cancer in the forseeable future."

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'Do-it-yourself' euthanasia clinic to open in Britain

By Severin Carrell
Published: 09 October 2005
A controversial Swiss clinic which has helped nearly 40 British people commit suicide is to open an office in the UK because of growing demand, The Independent on Sunday can reveal.

Zurich-based Dignitas has begun discussions about setting up a British branch, even though it is illegal here to help someone commit suicide. In the past three years, 37 Britons have killed themselves at its clinic. It claims to have hundreds more British members.

The move comes as Britain's most senior church leaders this weekend mounted a concerted campaign to counter fresh moves in Parliament to legalise assisted suicide.

The Archbishop of Canterbury, Dr Rowan Williams, and his Catholic counterpart, Cardinal Cormac Murphy- O'Connor, are leading attacks on plans by a group of senior peers to table a new Bill allowing assisted suicide.

Up to 70 peers and Anglican bishops are set to speak in a major debate in the House of Lords tomorrow.

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