Hawaii Biotech starts clinical trial

The company is looking for a vaccine for the West Nile Virus

After about five years of research and development and more than $16 million in funding, Hawaii Biotech Inc., the state's largest and most long-standing life sciences company, has begun its first clinical trial study with its West Nile vaccine candidate.

The West Nile Virus (WNV), which is spread by exposure to infected mosquitoes, can cause serious, life-altering and even fatal encephalitis, said Dr. Elliot Parks, Hawaii Biotech's chief executive officer. There is currently no vaccine to halt the spread of WNV among humans although an equine WNV vaccine for horses was approved for sale in 2002, Parks said.

WNV infections in humans have been reported in all states except Hawaii, Alaska and Maine, according to the Centers for Disease Control and Prevention. WNV cases also have been reported in Europe, west and central Asia, Oceania, Africa, and the Middle East.

"This is among the first (vaccines for WNV), so clearly when we are successful we might be the first available vaccine," Parks said, declining to put a monetary value on this pioneering discovery which was developed with the intent to induce protective immunity in recipients.

Results from the first phase of clinical trials should be available within in a year, but more rounds of study will take place in 2009 and 2010 before Hawaii Biotech attempts to register its vaccine with the Food and Drug Administration, he said. A fourth post-marketing phase also will be conducted to gain additional information followed by a search for potential product partners, Parks said.

In addition to its important science contribution, the clinical study is an important milestone for Hawaii Biotech's maturation into a clinical stage company as well as the overall growth of the state's burgeoning biotech industry, he said.

"It's clearly important to the larger investment community that Hawaii can support thriving biotech companies," Parks said. "It also showcases our ability to be a clinical stage company, which is very important, because our job is ultimately to get the product into patients and we can't do that until we have a successful clinical trial."

The study, being conducted now on paid human volunteers at Covance, a drug development services company in Honolulu, is the first clinical trial for Hawaii Biotech. It also is the first local clinical trial for a local bio-tech company, said Lisa Gibson, president of Hawaii Science and Technology Council

"From the health care therapeutic side, they are the first local biotech company to undergo local clinical trials and that's a very big milestone for the state," Gibson said

The company's foray into clinical trials also will provide valuable job training for Hawaii's still relatively young biotech industry, she said.

In addition to its WNV work, Hawaii Biotech also is developing vaccines for dengue virus and seasonal and pandemic influenza, Parks said.

"I believe that the success of companies like Hawaii Biotech will validate that we can do this type of research in Hawaii and that our private startup companies can make progress," said Ted Liu, director of the state Department of Business, Economic Development & Tourism.