BiondVax’s flu vaccine is a “a quantum leap in technology” says its chairman Isaac Devash.Every year, over 100,000 flu sufferers are hospitalized in the U.S. due to complications. While most people overcome the perennial illness after a few days of high fever and bed rest, weaker segments of the population – babies, the elderly and the ill – are liable to die as a result of the flu. The annual damage caused by the flu to the economy of the U.S. alone is estimated at over $25 billion.

Now an Israeli company has developed a revolutionary nose drop vaccine for influenza which promises to protect people of all ages for five years against all present and future strains of the flu.

The patented vaccine – developed by startup BiondVax – has completed successful laboratory testing on mice and is now securing funds for clinical tests on humans. The vaccine is based on 20 years of research by Weizmann Institute of Science Professor Ruth Arnon, who earlier in her career was a senior member of the team that developed the breakthrough drug Copaxone for multiple sclerosis.

Conventional flu injections are good for only one season, as the virus mutates every year. According to Isaac Devash, chairman of BiondVax, their new vaccine is not dependent on variable strains, so it will be long-lasting and more protective. Only a single drop need be inserted in the nose to be effective, he says.

“It’s a quantum leap in technology,” he told ISRAEL21c. “It’s a totally different concept from other vaccinations. What generally happens today is that there are 120 monitoring stations globally that look for new strains of virus around the world. Once it shows up, they identify the surface of the virus and develop a vaccine to combat it.”

“Professor Arnon said ‘I don’t want to play that game’. It’s tedious work identifying new strains of the virus and there are always new ones coming up. She said let’s look conceptually at the virus – beneath the surface – to see if there are particular elements that don’t change. And then let’s make a vaccine out of those parts which are universal in all viruses,” explained Devash.

The influenza virus – or ‘flu’ – is an acute respiratory tract infection that can easily spread via coughing, sneezing or even hand-to-hand contact. During an epidemic, the virus infects 5%-20% of the entire population. Global pandemics occur every 10-15 years due to major antigenic changes in the virus and are independent of season. The ‘Spanish Flu’ pandemic took the lives of more people during the years 1918-1919 than did the First World War (20 – 40 million people).

Currently available vaccines are based on predictions as to which virus strain will be prevalent in the forthcoming season. Failure to correctly predict the prevalent strains and their unexpected antigenic changes are the main reason for the reduced level of efficacy demonstrated by currently available vaccines.

Devash said that Arnon’s lab in Rehovot tested the vaccine on “human mice,” – rodents in which a human immune system (white blood cells) have been introduced.

“The results were staggering. The humanized mice were vaccinated and then attacked by different strains of influenza. All of the vaccinated mice stayed alive, while the control group of mice who didn’t receive the vaccination all died,” he said.

This success rate among the ‘human mice’ predicts a high likelihood of success in human clinical trials, Devash added. The new vaccine activates both arms of the human immune system (B- & T-cells) resulting in over 95% protection.

“Our first milestone was to establish that the vaccine was effective on humanized mice. It was the proof concept which we needed to move ahead.” said Ron Babecoff, BiondVax ‘s founder and CEO.

The challenge ahead for BiondVax is to elicit similar results with humans during clinical trials. To that end, the company recently launched a $4 million financing round to finance human clinical trials of the intra-nasal flu vaccine.

Babekof said the company’s business model called for reached Phase II human clinical trials in 2006 at a cost of only $4 million. “If this stage succeeds, we can link up with a major strategic partner to carry out Phase III clinical trials. The strategic partner will pledge additional resources and register the vaccine worldwide,” he told Globes.

Babecoff, a veterinarian with 10 years of experience in the pharmaceutical industry started BionVax in 2000 after investigating new projects with business potential that were maturing in their labs. Once he looked into Arnon’s research, he knew he found the right project.

Arnon, 71, is a world-famous scientist whose list of prizes and honorary degrees includes the French Legion of Honor, the Wolf Prize for Medicine and the Israel Prize for Medicine. She’s published has published over 400 articles on immunology.

She decided to conduct research on flu viruses “because I thought that we needed a system that suited human beings, and we already know a lot about the flu virus. Another reason why I decided on it is that mice are sensitive to the same strains of flu as are human beings, so that research can be done on them in the lab. That’s a very important point. With HIV, for example, there is no reliable model in animals,” she told Ha’aretz.

Arnon sought to find a part of the viruses that remains fixed, even when the keys of the virus envelope change, in the hope that by identifying it, she would be able to find a way to prepare the body for any future invasion of viruses – without undergoing the complicated and expensive process of identifying the new keys that appear each season.

Arnon probed a protein called Hemagglutinin found on the surface of the flu virus and found that it hid a peptide which appeared when the virus attached itself to a living cell. She discovered that this hidden part remains fixed in all the viruses, even when the external envelope undergoes significant changes, which prevent the body from identifying the virus. Over the following 10 years, Arnon and her assistants succeeded in proving that this peptide could serve as a serum for a vaccine, which enables the immune system to recognize and to stop various flu strains.

After all the years of research and testing, Devash is optimistic that the funding will be found for the clinical trials and that they will prove to be successful. And he looks forward to the day when a five-year flu vaccine from Israel will be distributed around the world saving lives.