HIV/AIDS vaccine developed at Western proceeding to human clinical trials
DECEMBER 20, 2011 - London, Ontario CANADA - The first and only preventative HIV vaccine based on a
genetically modified killed whole virus has received approval by the United States Food and Drug Administration (FDA)
to start human clinical trials.
Developed by Dr. Chil-Yong Kang and his team at The University
of Western Ontario, with the support of Sumagen Canada, the vaccine (SAV001) holds tremendous promise, having
already proven to stimulate strong immune responses in preliminary toxicology tests with no adverse effects or
safety risks. It is the only HIV vaccine currently under development in Canada, and one of only a few in the world.
"FDA approval for human clinical trials is an extremely significant milestone for our vaccine, which has
the potential to save the lives of millions of people around the world by preventing HIV infection," says Kang, a
researcher and professor at Western's Schulich School of Medicine & Dentistry.
Western President Amit Chakma says, "This joint venture between Sumagen and Western is a prime example of what collaboration between
private industry and university researchers can achieve. Dr. Kang and his team are to be commended for their exceptional talent
and remarkable persistence in developing a vaccine that addresses a tragic health crisis affecting millions of people around
Dr. Dong Joon Kim, a representative of Sumagen Co. Ltd. says, "Our company has committed substantial resources to this project
since 2005 and we are very pleased to reach this milestone. It is our desire to continue growing our business in Canada and
being a part of the business community in London."
HIV/AIDS has killed more than 28 million people worldwide, and more than 35 million people currently live with
the virus infection. Since the virus was characterized in 1983, there have been numerous trials through pharmaceutical
companies and academic institutions around the world to develop vaccines; however, no commercialized vaccine has
been developed to date. Other HIV vaccines evaluated through human clinical trials have focused on either one
specific component of HIV as an antigen, genetic vaccine using recombinant DNA, or recombinant viruses
carrying the HIV genes. Kang's vaccine is unique in that it uses a killed whole HIV-1, much like the
killed whole virus vaccines for polio, influenza, rabies and hepatitis A. The HIV-1 is genetically
engineered so it is non-pathogenic and can be produced in large quantities.
Before it can be commercialized, the SAV001 vaccine must go through three phases of human clinical trials:
. Phase I, set to begin in January 2012, will double check the safety of the vaccine in humans, involving only 40
. Phase II will measure immune responses in humans, involving approximately 600 HIV-negative volunteers who are
in the high-risk category for HIV infection.
. Phase III will measure the efficacy of the vaccine, involving approximately 6,000 HIV-negative volunteers who
are also in the high-risk category for HIV infection.
Through WORLDiscoveries, Western's technology transfer office, Sumagen Canada has secured patents for the SAV001 vaccine in more
than 70 countries, including the U.S., the European Union, China, India and South Korea. The vaccine has been manufactured at a
bio-safety level 3 (BSL3) good manufacturing practice (GMP) facility in the U.S.
About Sumagen Canada
Located in The Stiller Centre for Technology Commercialization in Western's Research Park in London, Ontario, Sumagen Canada was
established in 2008 specifically to manage and support clinical development of Kang's vaccine. Sumagen Canada is a subsidiary
of Sumagen Co. Ltd., a Korean-based pharmaceutical venture company.
About The University of Western Ontario
Located in London, Ontario, The University of Western Ontario is one of Canada's leading research-intensive universities, committed
to producing generations of talented leaders and innovations of national benefit and global value and
MEDIA CONTACT: Jeff Renaud, Senior Media Relations Officer, The University of Western Ontario, 519-661-2111, ext. 85165, firstname.lastname@example.org
"Reproduced with permission - The University of Western Ontario"