Proof-of-concept animal studies show that a number of HBI prototype vaccine formulations against West Nile are efficacious in the well-validated golden hamster model; similarly, positive immune response data have been obtained in mouse models with a prototype vaccine against influenza virus. The Company intends to file an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA) to begin human clinical trials with its West Nile vaccine in 2007. Hawaii’s ethnically-diverse population makes it an ideal location to conduct such Phase I studies, and the local clinical research infrastructure is well-developed. Hawaii Biotech enjoys exceptional community and regional support, as Hawaii’s legislators work to diversify the State’s economy that currently, is heavily reliant on service-oriented industries.

Also in 2007, the Company has embarked on the development of its recombinant Influenza vaccine, designed to be safer than the current generation of Influenza vaccines manufactured in eggs. Once established, this technology could be applied to the development of a pandemic influenza vaccine as well. Finally, HBI’s dengue vaccine formulations have been tested in both mouse and primate studies for ability to induce protective immune responses. These studies have demonstrated that high titer virus neutralizing antibodies (PRNT) are induced by several candidate formulations and that these formulations protect against viremia following challenge with live dengue virus.

Hawaii Biotech has also generated $2 million in licensing royalties and product sales; spun-off a Federally-funded Drug Discovery division which acquired research projects involving Anthrax, Ebola and Botulism; now known as PanThera Biopharma, LLC; in addition to forming a separate privately-held biotechnology company, Cardax Pharmaceuticals, Inc. that is completing the preclinical development of a cardiovascular product candidate.