Human trials approval sought for AIDS vaccine

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By Communications Staff
Tuesday, June 30, 2009
An HIV/AIDS vaccine developed at The University of Western Ontario is set for the first phase of human trials.
 
Sumagen Canada today announced 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 vaccine, dubbed SAV001-H, was developed by Western’s Dr. Chil-Yong Kang who, with Sumagen, has completed safety and immunogenicity studies on animals. Kang is a professor at the Schulich School of Medicine & Dentistry.
 
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.  
 
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.  
 
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.  
 
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. 

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