Advanced BioScience Laboratories, Inc. to Manufacture Hawaii Biotech, Inc.'s Dengue Vaccine for Clinical Trial

HONOLULU, HI and KENSINGTON, MD--(Marketwire - May 25, 2010) - Hawaii Biotech, Inc. and Advanced BioScience Laboratories, Inc. (ABL) announced today they are partnering for preclinical development of a dengue vaccine. Hawaii Biotech plans to begin a company-sponsored Phase 1 human clinical study with its tetravalent dengue vaccine candidate later this year. Under a contract from the National Institute of Allergy and Infectious Diseases (NIAID), ABL will oversee the manufacture, assembly and testing of supplies.

Hawaii Biotech is developing a tetravalent dengue virus sub-unit vaccine designed with high fidelity to all four of the native viral antigens, which it believes will provide balanced protective immunity to the recipients. The vaccine is nonreplicating, which Hawaii Biotech expects will result in a positive safety profile as compared to live-attenuated vaccines.

“In preparing to evaluate our tetravalent dengue vaccine in the clinic, we looked for a contract research organization with deep experience in viral vaccine development. ABL is that organization. Its long-standing and successful relationship with NIAID has led to discoveries that have advanced our understanding of other viral diseases and led to the development of safe and efficacious vaccines,” stated Hawaii Biotech, Inc. President and CEO Elliot Parks, Ph.D.

“Advanced BioScience Laboratories is pleased to continue working with the NIAID and to collaborate with Hawaii Biotech,” said Dr. Thomas VanCott, president and CEO of ABL. “We are making significant progress together and are proud to be part of this critical effort to bring this dengue virus vaccine candidate to the clinic.”

Parks noted that the three-way collaboration clearly helps Hawaii Biotech move forward more rapidly than it could alone and estimates it could save the company in excess of $2 million. Hawaii Biotech plans to begin a Phase 1 human clinical study with its tetravalent dengue vaccine candidate later this year.

This project will be funded in whole with Federal funds from NIAID of the National Institutes of Health (NIH) in the Department of Health and Human Services (DHHS), under Contract No. HHSN266200400045C.

Hawaii Biotech, Inc. (HBI) is a privately held biotechnology company focused on the development of prophylactic vaccines for infectious diseases. HBI has developed a proprietary protein production platform that has application to the manufacture of proteins for use as antigens in vaccines and diagnostic kits as well as research tools. HBI recently successfully completed a Phase 1 clinical trial of its West Nile vaccine in healthy human subjects. The company is currently in Phase 1 clinical studies with a monovalent dengue vaccine candidate and in pre-clinical development with a vaccine for tick-borne encephalitis. HBI’s product pipeline also includes vaccine candidates for malaria and influenza. Hawaii Biotech, the oldest and largest biotech company in Hawaii, is headquartered in Honolulu. For more information, please visit: http://www.hibiotech.com.

Advanced BioScience Laboratories, Inc. (ABL) is a Maryland biomedical contract research organization dedicated to advancing vaccine, microbicide, and therapeutic research. Through decades of experience in virological research, ABL has made major contributions to HIV vaccine research, developing the methods and technology to now allow ABL to broaden its capabilities into research and vaccine development for a wide array of infectious diseases. ABL has extensive experience working with diverse organizations, inducing various government and commercial entities, and has expertise in discovery and preclinical research and development of biopharmaceuticals. Since 2001 ABL has been a part of the Institute Merieux, a group of four companies dedicated to developing translational science for better patient care globally. Notable services include basic research, product design, process and assay development, preclinical in vivo models (including immunomonitoring), and Phase 1/2 cGMP biologics manufacturing. For more information, please visit www.ablinc.com.

Dengue, also known as “break-bone fever,” is a prevalent infectious disease in tropical and subtropical countries throughout the world. Approximately 3.5 billion people live in endemic countries and about 100 million people are infected with dengue every year. Dengue infections result in an estimated 20,000 deaths. Dengue is caused by one of four closely related, but distinct, virus serotypes (DENV1, DENV2, DENV3, and DENV4), of the family Flaviviridae, which also includes yellow fever, West Nile, Japanese encephalitis, and tick-borne encephalitis viruses. Dengue is transmitted by the bite of a mosquito infected with any one of the four dengue viruses. Infection with dengue virus results in severe flu-like symptoms that can lead to a life-threatening hemorrhagic fever. During the last quarter century, many tropical regions of the world have seen an increase in dengue cases. The southern United States is potentially susceptible to dengue epidemics as the types of mosquitoes that transmit dengue virus are prevalent there. Dengue cases were reported in southern Florida in late 2009.