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The Honolulu Advertiser
Posted on: Friday, June 30, 2006

West Nile vaccine may be tested here

Advertiser Staff and News Services

Hawaii Biotech Inc. aims to start human clinical trials for a West Nile virus vaccine during the first half of next year, and also is making progress toward an avian flu vaccine, the company's chief executive said yesterday.

'Aiea-based Hawaii Biotech intends to test the safety of its West Nile vaccine on about 50 patients, Leonard Firestone said. The trials will be conducted in the Islands, he said.

Hawaii Biotech expects to submit its application for clinical trials to the Food and Drug Administration later this year.

Authorization for the trials would be significant, because it would tell others the FDA scrutinized Hawaii Biotech's procedures and judged the firm competent.

"It's a big deal," Firestone said. "It's an important milestone in the history of the company."

The firm also is working on a vaccine for avian flu. Firestone said that Hawaii Biotech is still in the laboratory research phase on that project, but expects to reach the clinical stage in about a year.

Firestone said the company is making progress and he's "very optimistic" that a vaccine will be developed.

"Our company is able to express certain parts of the flu virus that other companies so far have not been able to successfully express or manufacture," Firestone said.

"So we really, in many respects, are ahead of the pack."

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 has also caused severe neurologic illness, meningitis or encephalitis in more than 8,300 people.

Hawai'i has not had any reported case of the disease.

About 228 confirmed human cases of avian flu and 130 deaths have been recorded by the World Health Organization, according to its Web site.

Firestone said he hopes to raise $3 million from Hawai'i investors during July and August to help fund the clinical trials. It would match a $3 million investment from Avantogen, the Australian company that merged its vaccine business with Hawaii Biotech 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 a plan to develop vaccines for dengue fever and influenza.

The dengue 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 rapid production of a high-quality product in large volumes.

Such a capability would be valuable in the event of an influenza pandemic 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 that their technology doesn't allow for 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.

Audrey McAvoy of The Associated Press and Curtis Lum of The Advertiser contributed to this report.

Correction: Hawaii Biotech Inc.'s name was incorrect in a previous version of this story.