Hawaii Biotech Reports Phase 1 Results for West Nile Virus Vaccine

Hawaii Biotech announced successful Phase 1 clinical trial results of its West Nile Virus vaccine in healthy volunteers. Hawaii Biotech is developing a West Nile recombinant sub-unit vaccine to induce protective immunity in recipients of the vaccine

HONOLULU, HAWAII | February 25, 2009 | Hawaii Biotech, Inc., today announced successful Phase 1 clinical trial results of its West Nile Virus vaccine in healthy volunteers. Hawaii Biotech is developing a West Nile recombinant sub-unit vaccine to induce protective immunity in recipients of the vaccine.

The results demonstrated a favorable safety profile in 24 subjects across four cohorts. The Phase 1 study was designed as an ascending dose study to assess the safety of Hawaii Biotech’s West Nile Virus vaccine among healthy adult volunteers who had not been exposed to the West Nile or similar virus. The study also examined antibody development to the vaccine. The overall profile was favorable with no serious adverse events. Based on these results, Hawaii Biotech is preparing to proceed with additional safety studies in adults, as well as ultimately expanding studies into elderly, juvenile and immunocompromised populations.

“We are extremely pleased with the safety results of our West Nile Virus vaccine Phase 1 study and are encouraged by the presence of neutralizing antibodies in all individuals receiving the formulated vaccine,” notes Chief Executive Officer and President Dr. Elliot Parks. “Additionally, these results demonstrate the robustness of our protein production platform for the development of additional sub-unit vaccines in our product pipeline,” Parks states.

Hawaii Biotech’s recombinant DNA technology platform allows the manufacture of proteins without the need for infectious virus. These viral proteins are not infectious, do not cause disease and are the basis for Hawaii Biotech’s sub-unit vaccines, including its vaccine for dengue fever. The dengue vaccine is expected to protect vaccine recipients against both dengue fever and dengue hemorrhagic fever. Hawaii Biotech is scheduled to begin its dengue vaccine clinical trials this year.

West Nile Virus, spread by exposure to infected mosquitoes, can cause serious, life-altering and even fatal disease. The most serious manifestation of West Nile Virus infection is fatal encephalitis. According to the Centers for Disease Control and Prevention, cases of West Nile Virus infections in humans have been reported in all states except Hawaii, Alaska and Maine. West Nile Virus has been reported in Europe, western and central Asia, Oceania, Africa, the Middle East, and since 1999, in North America. It has now spread into South America as well.

About Hawaii Biotech Inc.:

Hawaii Biotech, Hawaii’s oldest and largest biotech company, is a privately held biotechnology company focused on the research and development of prophylactic vaccines for infectious diseases. Hawaii Biotech has developed a proprietary protein production platform that has application to the production of proteins for use as antigens in infectious disease vaccines. In addition to its work on a West Nile Virus vaccine, the company is also developing vaccines for dengue virus and has a pipeline which includes vaccine candidates for malaria, tick borne encephalitis virus and influenza. Hawaii Biotech is headquartered in Honolulu. For more information, please visit: http://www.hibiotech.com.

SOURCE: Hawaii Biotech, Inc.

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