July 1, 2009
Human trials sought for AIDS vaccine
Scientists said an HIV/AIDS vaccine developed at Canada's University of Western Ontario is ready for the first phase of human trials.
Officials at Sumagen Co. Ltd., the manufacturer of the vaccine, said they have submitted an investigational new drug application to the U.S. Food and Drug Administration to begin Phase 1 human trials for its SAV001-H AIDS vaccine.The vaccine was developed by Professor Chil-Yong Kang who, with Sumagen, has completed safety and immunogenicity studies on animals.
University officials said Sumagen Canada has secured patents for the vaccine in more than 70 nations, 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.
The Phase l clinical trials, if approved, will double check the safety of the vaccine using HIV positive volunteers, the university said in a statement.
The second stage -- Phase ll trials -- would then assess the immunogenicity of the vaccine.