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The Honolulu Advertiser

Updated at 11:47 a.m., Monday, January 7, 2008

Hawaii Biotech gets OK for West Nile vaccine trials

Advertiser Staff

'Aiea-based Hawaii Biotech Inc. has received U.S. Food and Drug Administration approval to begin early-phase human trials of a vaccine against the West Nile virus.

The trial, which would be conducted on 24 volunteers, is contingent on the company receiving an unspecified added investment.

Hawaii Biotech is one of numerous companies working on a vaccine for West Nile, which last year resulted in 3,404 incidents of disease and 98 deaths in the United States, according to the U.S. Centers for Disease Control and Prevention.

Hawaii Biotech President and Chief Executive Carolyn Weeks-Levy was unavailable to comment on where the trials would be conducted.

"This is a substantial milestone for the company as it is a novel vaccine candidate with which the FDA has had little experience," she said in a news release. "Receiving this notification from the FDA that we may proceed to human clinical trials is the first step in proving our technology in a clinical setting and to the scientific community."

Results of the trial may be available by year's end depending on the trial's start date.