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Hawaii Biotech Receives Allowance To Perform West Nile Vaccine Clinical Trials
Hawaii Biotech, Inc. announced
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 candidates that have been shown to elicit
protective immune responses in animal efficacy models for diseases such as
West Nile, dengue, influenza, Ebola, malaria and tick-borne encephalitis.
"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," said Dr. Carolyn
Weeks-Levy, President and CEO of HBI.
Currently there is no vaccine for the prevention of West Nile disease
in humans; 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
influenza. Hawaii Biotech is headquartered in Honolulu, Hawaii. For more
information please visit: http://www.hibiotech.com.
Hawaii Biotech, Inc.
http://www.hibiotech.com
Hawaii biotehnologie Primeºte Allowance Pentru a efectua West Nile Vaccin studiile clinice - Hawaii Biotech Receives Allowance To Perform West Nile Vaccine Clinical Trials - articole medicale engleza - startsanatate