clinical trials

Acclaimed scientist preps first skin cancer vax trial

John Carroll — Thu, 20 Nov 2008 08:35:03 -0500

Australia's Ian Frazer has been using his knowledge of human papilloma virus to create an experimental jab to prevent skin cancer. And now he says he's ready to launch the first human trial of a new vaccine that has already proven effective in preventing skin cancer in animals.

In the study, researchers will vaccinate girls aged 10 to 12 and track its effectiveness in preventing skin cancer as they age. Sunny Australia has the highest rate of skin cancer in the world, with 1,600 people dying from the cancer each year. As with the HOV vaccine Gardasil, the vaccine targets the papilloma virus, which spurs abnormal cells to turn cancerous.

"My entire career has been focused on understanding the interaction between papillomavirus and the cancers they affect,'' Prof Frazer told the Daily Telegraph. "We know it causes at least five per cent of all cancers globally so one in 20 of the cancers that people get is caused by papilloma virus. It's a huge issue.''

- read the report from the Daily Telegraph

HPV researcher calls for vaccination of males

Calisha Myers — Mon, 10 Nov 2008 16:04:14 -0500

Discussion of the benefits of vaccination against the human papilloma virus (HPV) almost always centers around women, especially young women, who are at greater risk of developing cervical cancer. Speaking at an event in Canada late last month, the Nobel Prize winning pioneer of HPV research, Dr. Harald sur Hausen, called for the vaccination of men as well. As in women, the more dangerous strains of the virus, HPV-16 and HPV-18, can contribute to the development of anal and penile cancer.

Studies by the CDC indicate that homosexual men are at an even higher risk than heterosexual men; gay and bisexual men may be up to 17 times more likely to develop anal cancer.

The HPV vaccine Gardasil is not yet approved for men, but the manufacturer, Merck, is currently conducting clinical trials to determine the effectiveness of Gardasil in males. Merck spokeswoman Sheila Murphy says she is hopeful that preliminary data for the study will be available soon. "There is going to be a [peer reviewed] meeting in Europe in November, and I was hoping there would be some data presented there, and I still haven't heard whether that is going to be the case or not," Murphy tells Canada's Xtra.

But, Murphy said, it may be another two years before there is a vaccine for men on the market. Although some countries have allowed boys to be given Gardasil based on initial studies, others, such as Canada, have asked for efficacy studies. "In Canada... they want us to do the efficacy studies, to show in fact that the vaccine, not only does it cause an immune response recognition, but it actually prevents a disease," she said.

- check out Xtra article for more

GSK kickstarts global trial for seasonal flu vax

Calisha Myers — Mon, 10 Nov 2008 14:47:00 -0500

GlaxoSmithKline announced that it has started a worldwide clinical efficacy trial to evaluate a new seasonal flu vaccine. With over 43,000 volunteers, this Phase III clinical trial is one of the largest influenza efficacy trials ever undertaken for seasonal flu. The trial will be conducted over a two-year period and will involve adults aged 65 and older in 15 countries, including Belgium, France, United Kingdom, Germany, Russia, Mexico, United States, Taiwan and Canada.

"With this large clinical trial in seasonal influenza, we are building on the leading role GlaxoSmithKline Biologicals has already played in the development of pandemic protection. This new seasonal vaccine contains an adjuvant similar to the one pioneered for the only influenza pre-pandemic vaccine approved in Europe, Prepandrix, and the pandemic vaccine Pandemrix," said Jean Stéphenne, President and General Manager GSK Biologicals. "We are looking to develop a superior influenza vaccine that will provide those at risk of influenza with better protection."

- check out the GlaxoSmithKline release

ALSO: GSK has teamed up the PATH Malaria Vaccine Initiative, an anti-malaria organization funded by the Bill & Melinda Gates Foundation, and clinics and research centers in Africa to develop the world's first malaria vaccine. The massive clinical trial will include 16,000 children and is expected to begin as early as next month. Article

Proteins targeted in hunt for universal flu jab

John Carroll — Thu, 11 Sep 2008 09:07:26 -0400

Scientists at Oxford University are testing a new universal flu vaccine that targets the internal proteins of the virus, which change very little from one strain to the next. The Phase I trial involves 12 volunteers.

"The current approach to influenza vaccination is unsatisfactory for use against seasonal influenza and of little use when new types of flu begin to infect humans from birds," said Dr. Susan Gilbert of the Jenner Institute at the University of Oxford, which is leading the research. "It leaves manufacturers with just a few months to produce the necessary stocks, the vaccine then has to be administered to at-risk populations within a short time window, and those receiving the injection will have to be vaccinated again every year. By targeting the internal proteins of the virus, we can come up with a universal flu jab. The same vaccine would work against all seasonal flu and protect against bird flu."

- read the story in Medical Laboratory World

Hawaii Biotech moves West Nile vaccine into clinic

Thu, 10 Jan 2008 06:59:55 -0500

Hawaii Biotech has passed a key milestone in its development, winning approval to begin a small human trial of its experimental vaccine to combat West Nile disease. Hawaii Biotech says that the FDA has given its researchers a green-light for a 24-person trial, which is slated to begin in April, pending full funding. Data may arrive as early as the end of this year. Hawaii Biotech is in a race to develop the first West Nile vaccine, banking on years of work producing high quality recombinant proteins that have been used in labs from Hawaii to Harvard. The West Nile virus has killed more than 1,000 people in the U.S.

"The West Nile vaccine will be the first candidate to enter clinical trials for Hawaii Biotech. This is a substantial milestone for the company as it is a novel vaccine candidate with which the FDA has had little experience. Receiving this notification from the FDA that we may proceed to human clinical trials is the first step in proving our technology in a clinical setting and to the scientific community," says Dr. Carolyn Weeks-Levy, President and CEO of HBI.

It's also been a long time in coming, as she notes to FierceVaccines. The company was founded in 1982 and has been fueled by a combination of $30 million in investment capital and some $50 million from grants and other sources. "These (trial) funds will come from private investors or VCs," says Weeks-Levy. But she's staying mum on the company's venture backers.

- see Hawaii Biotech's release
- read the report from the Honolulu Star-Bulletin