Hawaii Biotech, Inc., President and CEO Elliot Parks, Ph.D., announced today that the company has initiated a Phase 1 clinical trial study with its West Nile vaccine candidate. The study, being conducted with healthy subjects, is the first clinical trial for the company.
This clinical study is an important milestone in Hawaii Biotech¹s maturation into a clinical stage company,² Parks notes.
West Nile Virus (WNV), spread by exposure to infected mosquitoes, can cause serious, life-altering and even fatal disease. The most serious manifestation of WNV infection is fatal encephalitis. According to the Centers for Disease Control and Prevention, cases of WNV infections in humans have been reported in all states except Hawaii, Alaska and Maine. WNV has been reported in Europe, west and central Asia, Oceania, Africa, the Middle East, and since 1999, in North America.
The Hawaii Biotech West Nile vaccine candidate is a recombinant sub-unit vaccine developed with the intent to induce protective immunity in recipients.
The first phase of a clinical development program is designed to assess safety, determine a dosage range and identify potential side effects. There are two additional clinical phases prior to FDA registration and a fourth post-marketing phase to gain additional information.
This clinical study, which will be recruiting volunteers for four treatment groups, is being conducted at a Phase 1 trial site in Honolulu. Results should be known within a year.
About Hawaii Biotech, Inc. Hawaii Biotech, Hawaii¹s 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 vaccine, the company is also developing vaccines for dengue virus and seasonal and pandemic influenza. Hawaii Biotech is headquartered in Honolulu. For more information, please visit: http://www.hibiotech.com.
