Release issued 2nd July 2009

An HIV/AIDS vaccine developed by University of Western Ontario professor Chil-Yong Kang has reached "an important milestone" as it pushes towards the first phase of human trials.

Sumagen Canada announced this week it has submitted an Investigational New Drug application to the United States Food and Drug Administration to begin Phase 1 human trials for its SAV001 AIDS vaccine.

"The application for the approval of Phase 1 human clinical trials is a very important milestone for our vaccine development," he says.

"We hope this vaccine is it, and hopefully this vaccine will prevent HIV infection and save millions of lives."

A professor at the Schulich School of Medicine & Dentistry, Kang, along with Sumagen, has completed safety and immunogenicity studies of the vaccine, dubbed SAV001-H, on animals.

The Phase l clinical trials, if approved, will double check the safety of the vaccine using HIV positive volunteers. The second stage - Phase ll trials - would then assess the immunogenicity of the vaccine.

Human trials are necessary to test the efficacy of the vaccine in protecting against HIV infection because the HIV virus does not cause AIDS-like symptoms in animals, says Kang. However, the immune responses in the animal trials have been promising, he says.

The FDA review process is expected to take two or three months.

"We expect to get the answers by October," says Kang. "We do not anticipate major problems with this."

Since the AIDS virus was recognized in 1983, there have been numerous trials through pharmaceutical companies to develop vaccines; however, no commercialized vaccine has been developed to date.

If the vaccine is given the go-ahead to enter into human clinical trials, it will be at least four years before Kang expects to have statistically significant analysis, and possibly allow the vaccine to be marketed.

Through Western, Sumagen Canada has secured patents for the vaccine in over 70 countries in the world, including the United States, the European Union and Korea. According to the firm, animal testing has resulted in good antibody reactions in immunology tests, with no adverse effects or safety risks.

Sumagen says it is prepared to begin the clinical trial in the U.S. as soon as approval is granted.

London and Western are also on a short list of Canadian cities being considered by the federal government for the building of an $88-million HIV vaccine manufacturing facility. Part of the funding for the facility will come from the Bill and Melinda Gates Foundation.

Kang is hopeful London and Western's bid will be successful, as having a facility closer to home will help his research. It would also be more convenient.

"When we were looking for facilities like this to manufacture our vaccine we could find only a few around the world," he says. "This kind of facility near us would help us to manufacture our candidate vaccine and also future vaccines."

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