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

VLP tech recognized as top-10 medical innovation

John Carroll — Thu, 20 Nov 2008 08:32:48 -0500

The Cleveland Clinic has recognized Novavax's use of genetically engineered virus-like particles in new vaccines as one of the year's top 10 medical innovations at its annual innovation summit.

Novavax develops recombinant structures that essentially look like a virus but don't have the genetic material needed to make them dangerous. Because they look like virus particles to the immune system, the body mounts a potent response that can stop the actual virus in its tracks. And the company says its technology is far less expensive and will be far more efficient in production.

"VLPs represent a very promising approach to preventing the spread of influenza as we recently demonstrated with the announcement of favorable results in a Phase IIa human clinical trial of our VLP based pandemic influenza vaccine," said CEO Dr. Rahul Singhvi.

- read the report from Medical News Today

Merck plans big vaccine expansion in India

John Carroll — Thu, 20 Nov 2008 08:31:52 -0500

Merck is beefing up its sales and marketing forces in India as it aims at evolving into the country's biggest vaccine supplier by 2013. According to a report by FinancialWire, Merck says it will hire some 1,500 people in India as it expands on the two vaccines it already markets on the subcontinent. The pharma giant is following in the footsteps of GlaxoSmithKline and Sanofi-Aventis, which have already established ambitious vaccine groups in India.

Slightly more than a third of the country's 1 billion citizens are under the age of 14, offering a huge market for pediatric vaccines. One in six Indians are under the age of six. And the government has been conducting mass education campaigns aimed at educating its huge population about the need for vaccines.

India, meanwhile, has already established a reputation as a low-cost center for vaccine manufacturing and research. According to a report from the research firm RNCOS, roughly two thirds of the low-cost vaccines made in India are exported to other countries.

- read the report from Trading Markets

In Phase III, Gardasil prevents HPV in men

Maureen Martino — Thu, 13 Nov 2008 14:28:26 -0500

It looks like Gardasil may not just be for girls anymore: a Phase III study of Merck's HPV vaccine found that the jab prevented 90 percent of external genital lesions caused by the disease men aged 16 to 26. In a study of 4,000 men, only three subjects who got the shot developed lesions; there were 31 cases in the placebo group. Gardasil prevents lesions caused by types 6, 11, 16 and 18

Merck said that the company remains on track to submit an sBLA for Gardasil for use in men by the end of 2008. The findings were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference.

- see Merck's release
- read the WSJ blog post

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

Big DNA gains new backing to advance vax tech

John Carroll — Thu, 06 Nov 2008 08:50:58 -0500

An international consortium has invested £1.5 million in Scotland's Big DNA. The money is being used to advance the biotech company's technology using bacterial viruses to deliver vaccines. These bacteriophages include the genetic code, or DNA, rather than the disease organism.

"In the current financial climate, this investment confirms the strength of our new technology for delivering vaccines to humans and animals, the vast potential of the market and the strength of the management team we are putting in place," said founder and CEO Dr John March. "Our patented technology has enormous potential importance for public health and this investment comes at a time when it must be the hardest in living memory to raise finance."

Clinical trials of the DNA vaccine are expected in about two years.

- check out the report from The Scotsman

Merck starts work on vax R&D center

John Carroll — Thu, 06 Nov 2008 08:29:06 -0500

Merck is preparing to launch construction of a €200 million vaccine R&D facility in the southeastern area of Ireland. The pharma giant says that construction will get started next year and should wrap in 2010.

"The new vaccine and biologics facility will bolster our expanding global vaccines business, which includes products to protect against hepatitis, zoster, rubella, measles and haemophilus," said Merck. "The project will create 170- new high-quality jobs by 2011 across all areas of management, quality control, engineering, research and development and administration."

Irish officials lauded the move as another sign of the country's growing role in biotechnology.

- read the story in Medical Laboratory World