Sumagen Canada today announced that it has submitted an IND (Investigational New Drug) application to the United States Food and Drug Administration to begin Phase 1 human trials for its SAV001 AIDS vaccine. 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. The unique Sumagen vaccine, entitled, SAV001-H, was developed by Dr. Chil-Yong Kang, Professor at The University of Western Ontario. Kang and Sumagen have already completed safety and immunogenicity studies on animals.
Through The University of Western Ontario in London, Ontario, Sumagen Canada has secured patents for the vaccine in over 70 countries in the world, including the United States, the EU and Korea.
While the company has faced a number of challenges throughout the production process, 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 is prepared to begin the clinical trial in the U.S. as soon as approval is granted.
Dr. Kang is available for media interviews, via phone from Korea, from 10 a.m. to 11:30 a.m. EST, today, June 30.
Note: London and the The University of Western Ontario are on a short list of Canadian cities that are 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.
Contact: Ann Hutchison, Director of Media Relations, The University of Western Ontario, 519-661-2111, ext. 85468, ahutch2@uwo.ca
