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, influenza, dengue fever, 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, seasonal influenza, 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.

Seasonal Influenza
Each year an estimated 20% of the U.S. population will develop "seasonal" influenza, and a substantial proportion of those afflicted will be hospitalized. On average, 36,000 deaths per year can be attributed to this disease with deaths climbing to 100,000 or more during pandemic years. The elderly (> 65 years) and the very young are most susceptible to complications from the annual influenza virus.

Currently about 80 million Americans receive flu vaccine each year. This is in contrast to the 185 million Americans that the U.S. Advisory Committee on Immunization Practices recommends for vaccination. It is estimated that to meet vaccination demands during an influenza pandemic that 280 to 575 million doses of vaccine would be required for the U.S. population (DHHS, 2004). The current global influenza market is estimated to be $1.5 billion annually, and analysts believe that the market could be $4 billion for the right product (New York Times, 1997). These market estimates do not take into account the increased number of doses that would be needed during pandemic influenza outbreaks. Therefore, the development of a recombinant subunit protein vaccine for influenza, such as the method being developed at Hawaii Biotech, which eliminates the need to utilize embryonated chicken eggs, and is safe and effective, has great potential to satisfy this exceptionally lucrative market.

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 achieved protection 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 two NIH-NIAID grants and a grant from the Pediatric Dengue Vaccine Initiative.