BiondVax`s universal vaccine is based on research carried out for the past 15 years by Weizmann Institute Professor Ruth Arnon who serves as the company`s Scientific Advisor.
Arnon is well-known for her part in ground-breaking research on multiple sclerosis that led to Teva`s Copaxone drug which this July passed the billion dollar mark in sales. In parallel to her work in autoimmune diseases, Arnon worked on finding a universal flu vaccine based on conserved epitopes—fragments on the outer shell of a virus that never change. This month she will be presenting her research at the World Health Organization in Geneva.
``The bird flu virus came just this year, but we had been working on the topic of developing a universal flu vaccine for many years,`` says Arnon from her research lab at the Weizmann Institute. ``At this point in our research, we don`t know for certain if our vaccine will work against the bird flu,`` she cautions. She believes that it will be possible to develop a universal vaccine and believes that international efforts have been strengthened by US President Bush`s recent allocation of $7.1 billion funding for this purpose.
Traditionally, influenza vaccines are made new every year since the virus mutates rapidly. Vaccine manufacturers are told by public health officials what virus strains can be expected and the companies produce vaccine based on that projection. But that projection is pretty much a hit-and-miss explains BiondVax`s founding chair Isaac Devash, who says that a traditional flu vaccine works only 50% of the time.
Devash and other medical professionals fear that if a deadly virus such as the bird-flu should mutate rapidly it is unclear just how effective current vaccines will be. BiondVax believes that when immunized with the company`s universal flu vaccine, a person will be protected against influenza strains from the past, present and future.
The conserved epitopes, which Arnon has amplified, have been found to be preserved in the virus strains regardless of antigenic drifts and shifts. When isolated and magnified through a biological process, the result will be a needle-less, inhaled epitope cocktail which is expected to activate the human immune system and provide protection to mutating strains of influenza strains for several years. Preclinical experiments in animal models have proven the vaccine to be effective. Further animal studies and toxicity tests will be done in part by Israel`s Veterinary Institute in the coming months.
Initial animal studies were investigated by Arnon and Tami Ben-Yedidia at the Weizmann Institute on a humanized mice model. In the model, the human immune system was transplanted in mice in order to see how the human immune system responded to BiondVax`s vaccine. In all these tests the vaccine turned out to be more than 95% effective against a variety of strains of influenza. Moreover, immunity continued to exist for at least 25% of the life of the mice.
``Although it may be an irrational fear, it is just a matter of time until the next big virus hits the world,`` says Devash, a Harvard Business Graduate, who helped establish BiondVax in 2003. The universal vaccine is expected to be commercialized in 3 to 4 years; development time cut in half should the bird flu virus become an epidemic. The company is hoping to find a US partner in order to access the recent Bush Administration funding. Phase I clinical trials are expected to begin January, 2007 once the company concludes its pre-clinical work.
``We are now checking the recognition of the antibodies that an animal creates after vaccinations against the specific of the H5N1 (avian flu),`` reported company president and CEO Dr. Ron Babecoff, a veterinarian and entrepreneur.
The race to be the first in the market with a universal flu vaccine is now underway. BiondVax could very well be the winner. ``We have the potential to offer a paradigm shift in the vaccination industry,`` concludes Isaac Devash.
Karin Kloosterman
Source: "here":[ http://www.bioisrael.com/].