Hawaii Biotech has passed a key milestone in its development, winning approval to begin a small human trial of its experimental vaccine to combat West Nile disease. Hawaii Biotech says that the FDA has given its researchers a green-light for a 24-person trial, which is slated to begin in April, pending full funding. Data may arrive as early as the end of this year. Hawaii Biotech is in a race to develop the first West Nile vaccine, banking on years of work producing high quality recombinant proteins that have been used in labs from Hawaii to Harvard. The West Nile virus has killed more than 1,000 people in the U.S.
"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. 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," says Dr. Carolyn Weeks-Levy, President and CEO of HBI.
It's also been a long time in coming, as she notes to FierceVaccines. The company was founded in 1982 and has been fueled by a combination of $30 million in investment capital and some $50 million from grants and other sources. "These (trial) funds will come from private investors or VCs," says Weeks-Levy. But she's staying mum on the company's venture backers.
- see Hawaii Biotech's release
- read theÂ report from the Honolulu Star-Bulletin