Canada: Western University Researcher Finds Backer to Finance Clinical Trials of HIV/AIDS Vaccine

The University of Western Ontario announced recently that Korea-based Curocom Co. Ltd. will put up the $15 million Canadian ($13.3 million U.S.) needed to take an HIV/AIDS vaccine in development through Phase I and Phase II clinical trials. The vaccine was developed by virologist Dr. Yong Kang, who is hopeful but cautious about its chances of success.

"We have to be careful," Kang said. "Because we have done the animal, the immune response studies. But that doesn't mean we can repeat exactly the same kind of results in humans." Kang said Phase I and II human trials will take place in North America.

Phase I trials are small studies to determine if a drug or vaccine is safe for humans. Phase II trials begin to elicit information on whether the treatment or vaccine is effective. Phase III trials are large studies that provide data needed to persuade a regulatory agency that a drug or vaccine is safe and effective enough to market.

Currently, more than 30 HIV vaccines are in various stages of clinical trials, according to the International AIDS Vaccine Initiative. It has been estimated that at least as many more have been abandoned after work that looked promising in animal studies did not succeed in human trials. Two vaccines went to Phase III trials but proved ineffective.

Kang said if all goes well, his vaccine could be ready for use as a therapeutic, basically a treatment to clear the virus from infected people, in about three years. He estimates it would take twice that long to have a preventative vaccine tested and licensed.

Regulatory agencies such as Health Canada and the U.S. Food and Drug Administration must approve the trials before they can begin.

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