Successful Pre-Clinical Tests Support Vaccine Platform, New Injection Protocol
Raleigh N.C., March 18, 2013- Arbovax, Inc., a development-stage biotechnology company, has successfully demonstrated the validity of its vaccine technology in non-human primates and will now move to Phase 1 clinical trials with its unique dengue fever vaccine.
“We are exceptionally pleased with the results of this pre-clinical trial,” said Malcolm Thomas, president and CEO of Arbovax, “especially in light of some of the disappointing results from recent clinical trials involving vaccines under development by others. These results show we’re on track to produce a meaningful weapon against the global increase in dengue fever outbreaks.”
To test its far-reaching tetravalent vaccine, Arbovax employed an innovative immunization protocol. Researchers injected each of the four distinct strains (serotypes) of the actual dengue virus into a different limb of the animal.
This distribution eliminated the possibility of interference in virus replication. When two or more serotypes infect the same tissues, they may compete with one another, preventing a balanced immune response. The Arbovax approach requires only one round of inoculations with no boost, or adjuvant, required. This is especially significant for protecting people in developing nations with limited access to transportation and medical care.
All the vaccinated subjects developed antibodies to each of the four dengue serotypes. The vaccinated subjects also showed a marked increase in antibody response after they were challenged with the virus, indicating good protection, with low levels of potentially deleterious non-specific neutralizing antibody.
“The Arbovax tetravalent vaccine is the only vaccine of its kind. It combines good science and virus knowledge to overcome problems in the dengue biology that so far has made the dengue vaccine issue a very difficult task”, said Dr. Davis Ferreira, a leading researcher in dengue fever at the Federal University of Rio de Janeiro. “This new technology becomes very important mainly because all traditional approaches have failed so far. Also, the technology may be applied to other viruses that are transmitted by arthropods. I am very optimistic for the success of Arbovax’s new dengue vaccine.”
“The unique nature of these arboviruses supports the assertion from a number of sources that the best approach is a whole-virus vaccine,” said Thomas. “This is the basis of the Arbovax technology. As a result, we will be moving forward with our tetravalent vaccine to a phase 1 human trial as soon as is possible.”
Arbovax, based in Raleigh, is developing its novel and innovative platform technology for vaccines against the 200-plus arthropod-borne viral diseases that affect man. The company has received over $600,000 in loan support from the North Carolina Biotechnology Center since 2006.
The core technology, developed by Drs. Dennis Brown and Raquel Hernandez of North Carolina State University, provides a cost-effective way to address mosquito-borne diseases such as dengue fever, West Nile, Japanese encephalitis, chikungunya and yellow fever.
Arbovax’s initial focus is dengue fever because it is ranked second only to malaria by the World Health Organization for its devastating global impact with 2.5 to 3 billion people, more than 40 percent of the world’s population, at risk for infection. Recent outbreaks in South America, Brazil, India and parts of the United States highlight the worldwide spread of the disease.