HONOLULU – Hawaii Biotech Ltd. aims to start human clinical trials for a West Nile virus vaccine during the first half of next year, marking an important milestone for the startup, the company's chief executive said Thursday.
Aiea-based Hawaii Biotech intends to test the safety of its vaccine formula on about 50 patients, Leonard Firestone told The Associated Press. The trials will be conducted in the islands, he said.
The Food and Drug Administration still hasn't approved the plan and Hawaii Biotech isn't expected to submit its clinical trial application until later this year.
Authorization for the trials would be significant, because it would broadcast that FDA scrutinized Hawaii Biotech's procedures and judged them competent.
"It's a big deal," Firestone said. "It's an important milestone in the history of the company."
West Nile virus is a mosquito-borne disease that can cause life-threatening illness in humans, horses and birds. It has killed almost 800 people in the United States since it was first detected in this country in 1999.
The virus also has caused severe neurologic illness, meningitis or encephalitis in more than 8,300.
Hawaii has not had a case of the disease.
Firestone said he hopes to raise $3 million from Hawaii investors during July and August to help fund the clinical trials. It would match a $3 million investment from Avantogen, the Australian company which merged its vaccine business with Hawaii Biotech earlier this year.
Significant delays with this summer's fundraising, however, could jeopardize the clinical timeline, Firestone said.
Hawaii Biotech hopes to parlay any success with a West Nile virus vaccine into its plans to develop vaccines for dengue fever and influenza.
The dengue fever virus vaccine is on course to enter human clinical trials during the second half of next year, Firestone said.
Hawaii Biotech uses recombinant DNA technology to produce vaccines, allowing for the rapid production of a high-quality product in large volumes. Such a capability would be highly valued in the event of an influenza pandemic outbreak because public health officials would need to quickly acquire large volumes of vaccines once they identify the culpable virus.
Currently, flu vaccines are produced in specialized chicken eggs, but the technique does not allow for speedy mass vaccination.
Firestone said a few other companies also make recombinant vaccine but their technology doesn't produce as high-quality a product.
Firestone joined Hawaii Biotech from Avantogen, where he was also chief executive, when the two companies merged their vaccine businesses. He hopes to take Hawaii Biotech public by the middle of next year through an initial public offering, a merger with a public company, or some other method.