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The vaccine, developed at the University of Western Ontario, could be tested on humans as early as 2008, if FDA approval is granted.
London moves closer to AIDS vaccine
"It's possible we could begin human clinical trials by the middle of next year," the project's lead researcher said Aug. 24.
The final hurdle to clear is approval from the Food and Drug Administration in the United States where the tests would be done, said Yong Kang, a microbiology and immunization professor at Western.
"Progress is being made, but it's slow," he said.
Yang said test sites that meet strict research standards have been secured in Kensington, Md., and Carlsbad, Calif.
Arrangements have been made to conduct six more months of animal trials at the Charles River Laboratories in Montreal, Kang said.
The vaccine, developed over 19 years at a cost of $7 million, has been tested successfully in macaque and rhesus monkeys.
It has the potential to be useful in both the prevention and treatment of AIDS, said Kang, adding it will be produced in two formulations.
A U.S. patent has been issued, a U.S. manufacturer engaged and a Korean company has secured the marketing and distribution rights to the vaccine, already patented in 34 countries.
At Western last October, Dong Joon Kim, president of Curocom Co. Ltd., the Korean company, said the company had spent $20 million to procure the rights
He said Curocom could invest as much as $50 million more in the human trials process.
The company came on board because of the patents and Kang's international reputation as a virologist and researcher, Kim said.
The vaccine uses a combination of killed HIV virus, plus a virus genetically altered in the lab to carry the harmless HIV cells through the body to prompt an immune response.
Plans call for the vaccine to be tested on 30 humans in the first phase after FDA approval and about 300 in a second phase to determine its effectiveness and safety.
AIDS has killed 25 million people since it was discovered in 1981 and an estimated 43 million are infected with HIV, according to world health statistics.
London moves closer to AIDS vaccine
| Joe Matyas Sun Media |
August 25, 2007 |
If all goes well, a vaccine for the prevention and treatment of HIV/AIDS, developed at the University of Western Ontario, could be tested on humans in 2008.
| Plans call for the vaccine to be tested on 30 humans in the first phase after FDA approval. |
The final hurdle to clear is approval from the Food and Drug Administration in the United States where the tests would be done, said Yong Kang, a microbiology and immunization professor at Western.
"Progress is being made, but it's slow," he said.
Yang said test sites that meet strict research standards have been secured in Kensington, Md., and Carlsbad, Calif.
Arrangements have been made to conduct six more months of animal trials at the Charles River Laboratories in Montreal, Kang said.
The vaccine, developed over 19 years at a cost of $7 million, has been tested successfully in macaque and rhesus monkeys.
It has the potential to be useful in both the prevention and treatment of AIDS, said Kang, adding it will be produced in two formulations.
A U.S. patent has been issued, a U.S. manufacturer engaged and a Korean company has secured the marketing and distribution rights to the vaccine, already patented in 34 countries.
At Western last October, Dong Joon Kim, president of Curocom Co. Ltd., the Korean company, said the company had spent $20 million to procure the rights
He said Curocom could invest as much as $50 million more in the human trials process.
The company came on board because of the patents and Kang's international reputation as a virologist and researcher, Kim said.
The vaccine uses a combination of killed HIV virus, plus a virus genetically altered in the lab to carry the harmless HIV cells through the body to prompt an immune response.
Plans call for the vaccine to be tested on 30 humans in the first phase after FDA approval and about 300 in a second phase to determine its effectiveness and safety.
AIDS has killed 25 million people since it was discovered in 1981 and an estimated 43 million are infected with HIV, according to world health statistics.
Joe Matyas is a Free Press reporter.
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