Hawaii Biotech, Inc president and CEO Elliot Parks, announced that the company has initiated a phase-1 clinical study with their monovalent dengue vaccine candidate. The double-blind, placebo controlled, dose escalation safety study in healthy subjects is being conducted at the Saint Louis University Center for Vaccine Development.
"This dengue clinical study is an important milestone in Hawaii Biotech's maturation as a clinical stage company. In addition it confirms the versatility of our subunit vaccine technology platform," Parks noted. "This phase-1 study will also prepare us for the initial clinical testing of Hawaii Biotech's tetravalent dengue vaccine."
Hawaii Biotech's dengue monovalent vaccine candidate is the first recombinant subunit vaccine for dengue to enter clinical studies. Previous dengue vaccine candidates tested in the clinic have been either live-attenuated or DNA-based vaccines. Hawaii Biotech intends to test a dengue tetravalent vaccine candidate, developed using the company's recombinant subunit vaccine technology, within a year.
The first phase of clinical development program is designed to assess safety, determine a dose range and identify potential side effects. Results from this clinical study are expected within a year. Hawaii Biotech's dengue subunit vaccine candidate has been developed with financial assistance from the National Institutes of Health, the Department of Defense, and the Paediatric Dengue Vaccine Initiative.
Hawaii Biotech is a privately held biotechnology company focused on the research and development of prophylactic vaccines for infectious diseases.