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Tuesday, August 16, 2005
 
[ biotech news ] Hawaii Biotech's West Nile Vaccine Shows 100% Protection in Durability Study;

Hawaii Biotech's West Nile Vaccine Shows 100% Protection in
Durability Study; Third Study Confirms Vaccine Candidate's
Protective Efficacy

Hawaii Biotech, Inc., a privately held biopharmaceutical company
engaged in the research and development of human pharmaceuticals,
announced today that in a third study its West Nile vaccine
protected 100 percent of test animals from both illness and death
after six months when challenged with live West Nile Virus. In
contrast, 53.3 percent of the control animals died, and surviving
control animals all showed signs of illness. Two previous studies,
in which longer term durability was not assessed, also demonstrated
100 percent protection from both illness and death following live
West Nile Virus challenge. An additional study examining protection
at one year is underway.

The latest vaccine efficacy durability study was conducted in a well-
validated model of human West Nile disease, the golden hamster,
developed at the University of Texas Medical Branch. The study
consisted of three groups of fifteen animals each: one control group
and two groups immunized with Hawaii Biotech proprietary vaccine
formulations. Each group was vaccinated on day one, boosted on day
28 (controls were vaccinated and boosted with adjuvant only), and
then challenged six months post boost with a lethal dose of live
West Nile Virus. Morbidity and mortality were monitored for 30 days.
The results showed that all 30 animals that received Hawaii
Biotech's vaccine remained alive and healthy, with no signs of
illness at any time during the study. In contrast, all 15 control
animals, or animals that did not receive the vaccine became ill and
eight died with encephalitis.

The durability study was conducted by Dr. Douglas Watts, Professor
in the Department of Pathology, University of Texas Medical Branch
at Galveston, and complements two previous studies conducted at the
same university by Dr. Robert Tesh. "Vaccination is likely to be the
most effective measure against an infectious disease such as West
Nile," said Dr. Watts. "Hawaii Biotech's West Nile vaccine candidate
has demonstrated strong protective efficacy and good durability
extending out to at least six months."

Hawaii Biotech's genetically engineered, sub-unit vaccine technology
represents a potentially safer, non-infectious alternative to live
virus vaccines, which have an inherent risk of causing severe
disease in some people. Hawaii Biotech's proprietary sub-unit
vaccine, which combines a modern adjuvant with genetically
engineered viral proteins designed to eliminate the possibility of
viral disease, may confer a substantial safety advantage.

"We are very encouraged by the efficacy, durability and safety
profile of our West Nile vaccine candidate in these animal models,"
said David G. Watumull, President and CEO of Hawaii Biotech. "While
much work remains, these results support our goal of providing a non-
infectious vaccine that generates safe and effective protection
against West Nile Virus infection across all age groups.

About West Nile Virus

Virtually unknown in the U.S. prior to 1999, the West Nile virus is
now established throughout the U.S., Canada and Mexico (or North
America). Approximately 20 percent of those infected develop
systemic febrile illness, while about one out of 150 progress to
develop severe neurological symptoms. Approximately 5-14 percent of
the latter cases are fatal. Moreover, in a high percentage of the
non-fatal cases, permanent neurological disabilities result. These
clinical findings are significantly worse in elderly patients. The
CDC reported 2,539 cases and 100 deaths in 2004, with 1,141 (45
percent) of the 2,539 cases reporting neuroinvasive symptoms
(meningitis, encephalitis, or a poliomyelitis-like syndrome).

About Hawaii Biotech

Hawaii Biotech, Inc. is a privately held biopharmaceutical company
engaged in the research and development of human pharmaceuticals. It
is currently developing products from two broad product platforms:

-- Small molecules with potent anti-inflammatory activity but
without the side effects of steroids, aspirin, ibuprofen, Vioxx, and
Celebrex. First applications include: the reduction of peri-
procedural damage in angioplasty patients; and a treatment for
macular degeneration.

-- Targeted and rapid responses to emerging disease and
bioterrorism. First applications include safer, highly protective
vaccines for West Nile, dengue, and flu as well as small molecule
therapeutics for anthrax and dengue.

For more information, please visit www.hibiotech.com



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