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Hawaii Biotech Receives Allowance to Perform West Nile Vaccine Clinical Trial

From the Hawaii Biotech archive: HAWAII BIOTECH RECEIVES ALLOWANCE TO PERFORM WEST NILE VACCINE CLINICAL TRIALS
Hawaii Biotech Receives Allowance to Perform West Nile Vaccine Clinical Trial

Hi, Biotech is an independent publication with no affiliation with Hawaii Biotech, Inc. This page preserves a historical record from the company's original press archive, republished for research and archival purposes. Copyright in the original material remains with its original owner.

FOR IMMEDIATE RELEASE

Contact: Hawaii Biotech, Inc. Dr. Carolyn Weeks-Levy, CEO (808) 792-1323

HAWAII BIOTECH RECEIVES ALLOWANCE TO PERFORM WEST NILE VACCINE CLINICAL TRIALS

Honolulu, Hawaii, January 7, 2008 - Hawaii Biotech, Inc. announced today that it has been notified by the United States Food and Drug Administration (FDA) that it may proceed to initiate a 24 patient safety study in healthy human volunteers with its recombinant subunit West Nile vaccine. 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.

HBI develops subunit vaccine candi dates that have been shown to elicit protective immune responses in animal efficacy model s for diseases such as West N ile, dengue, influenza, Ebola, malaria and tick-borne encephalitis.

"The West Nile vaccine will be the firs t 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 provi ng our technology in a clinical sett ing and to the scientific community," said Dr Carolyn Weeks-Levy, President and CEO of HBI.

Currently there is no vaccine for the prevention of West Nile disease in hum ans; a disease that has caused over 25,000 cases of disease and over 1000 deaths since the virus was introduced in the U.S. in 1999.

About Hawaii Biotech, Inc.

Hawaii Biotech is a privately held biotechnology company focused on the research and development of prophylactic vaccines for infectious diseases. Hawaii Biotech has developed a proprietary protein production platform that has application to the production of proteins for use as antigens in infectious disease vaccines. In addition, to its work on a dengue vaccine the company is also developing vaccines for West Nile virus and seasonal influenz a. Hawaii Biotech is headquartered in Honolulu, Hawaii. For more information please visit: http://www.hibiotech.com