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news.Hawaii Biotech has received FDA's approval to initiate a 24 patient safety study in healthy human volunteers with its recombinant, subunit West Nile vaccine.
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The trial will be conducted at a single site in Hawaii, which the company currently expects to start in April 2008, pending successful completion of financing sufficient funding to complete the trial. Depending on the actual start date, results of the trial may be available by the end of 2008.
Carolyn Weeks-Levy, president and CEO of HBI, said: “The West Nile vaccine will be the first candidate to enter clinical trials for Hawaii Biotech. This is a substantial milestone for the company as it is a novel vaccine candidate with which the FDA has had little experience.”