Hawaii Biotech to start human trials
Hawaii Biotech Inc. has received government approval to conduct human clinical trials on its West Nile virus vaccine, marking a huge milestone for the Aiea-based company.
The U.S. Food and Drug Administration approved a 24-patient safety study that is expected to be conducted on Oahu beginning in April, pending the completion of financing for the trial.
Carolyn Weeks-Levy, Hawaii Biotech president and chief executive officer, wouldn't disclose how much the trial is expected to cost, though West Nile vaccine will be the company's first candidate to enter clinical trials.
"The market for West Nile is in the hundreds of millions of dollars," she said. "How much of that the company would capture I don't know."
While fewer than half a dozen West Nile vaccines are in the clinical trials stage, none are using the same technology as Hawaii Biotech, Weeks-Levy said.
"What it does for us is proves our vaccine manufacturing platform technology, which is applicable to other vaccines such as dengue and influenza," she said. "Given that West Nile is successful, it opens the door to the development of all these other vaccines."
West Nile disease, spread by infected mosquitoes, can be fatal and cause flu-like symptoms or severe illness such as paralysis and neurological disease that affects the ability to move, speak and do normal day-to-day activities.
Results of the trial could be available by year's end, the company said.
Hawaii Biotech has developed vaccine candidates that have been shown to decrease diseases such as West Nile, dengue, influenza, Ebola, malaria and tick-borne encephalitis in animal clinical trials.
"This is a substantial milestone for the company as it is a novel vaccine candidate with which the FDA has had little experience," Weeks-Levy said.
There is no vaccine for humans to prevent West Nile disease. There have been more than 25,000 cases of the disease in the United States since 1999, blamed for more than 1,000 deaths.
Hawaii Biotech hopes to apply for human clinical trials on a dengue fever vaccine with the FDA this year. The company has completed preclinical development work for dengue, including animal trials and testing.