Hawaii Biotech believes that its protein production platform for developing vaccines targeting numerous infectious diseases is well suited to meet requirements such as safety, production yield, rapid response, and efficacy. The Company’s vaccine technology is based on the production of high quality recombinant proteins using stable insect cell lines. The high quality of the proteins produced in this system result in immune responses equivalent to or better than traditional live or inactivated virus approaches. Furthermore, the purified recombinant proteins provide for a significantly improved safety profile. This platform technology is applicable to a wide variety of diseases including West Nile, dengue fever, tick borne encephalitis, influenza, hepatitis C, malaria, Japanese encephalitis, Ebola, Eastern equine encephalitis, and others. We are currently focusing our attention on the development of vaccines for West Nile, and dengue fever. Analysis by X-ray crystallography of one of HBI’s dengue proteins produced by this platform was featured on the cover of the journal “Nature” (January 22nd, 2004).

West Nile
Virtually unknown in the U.S. prior to 1999, the West Nile virus is now prevalent throughout the U.S. and Canada. While the majority of human infections result in mild to no symptoms, more severe forms of the disease can result in long term neuropathological effects and even fatalities. In mild cases flu-like symptoms are common but in the more severe cases encephalitis, meningitis, or polio-like symptoms are reported. In 2006 a total of 4,269 cases were reported by CDC across the U.S. One hundred seventy seven of these cases were fatal.

Unlike most human viral diseases, West Nile causes both disease and death in animals. A well-validated model of human West Nile disease, the golden hamster, has been developed by Robert B. Tesh, M.D., of the University of Texas Medical Branch--Galveston and one of the leading researchers in this field. Dr. Tesh and his colleague, Dr. Douglas Watts have conducted several studies using various formulations of Hawaii Biotech’s West Nile vaccine in this model. The results have shown that the vaccine provided 100% protection (all animals survived and remained healthy), while 50-75% of the control animals (animals not given vaccine) died and those not dying were sick.

Duane Gubler, ScD, former director of the Department of Vector Borne Infectious Disease (DVBID) at the Centers for Disease Control (CDC) and now Director of the Asia-Pacific Institute of Tropical Medicine and Infectious Diseases at the John A. Burns School of Medicine at the University of Hawaii is a consultant to Hawaii Biotech on this project.

Dengue
Dengue is expanding globally with an estimated 50 million to 100 million cases of dengue world-wide annually with more than 20,000 deaths. It is carried by mosquitoes and causes severe flu-like symptoms that can lead to a life threatening hemorrhagic fever.

Hawaii Biotech’s dengue vaccine solves previously insurmountable technical hurdles that have stymied dengue vaccine research for more than forty years. Using genetically engineered proteins from all four serotypes of dengue viruses, we are able to induce immunity in animals to all four dengue viruses - or “tetravalent immunity.” Alternative approaches have induced immune responses in humans against only one or two of the four dengue viruses, increasing the risk of the life-threatening, hemorrhagic form of the disease.

Animal efficacy trials have been completed and pre-clinical development is progressing with funds from NIH-NIAID grants and a grant from the Pediatric Dengue Vaccine Initiative.