HIV/AIDS vaccine developed at Western proceeding to human clinical
trials
http://www.healthcanal.com/drugs-approvals-trials/24918-HIVAIDS-vaccine-developed-Western-proceeding-human-clinical-trials.html21/12/2011 15:18:00
By Communications Staff - 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.
For supporting video and images, please visit http://communications.uwo.ca/media/hivvaccine/
"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 the globe."
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 HIV-positive
volunteers.
• 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 significance.
MEDIA CONTACT: Jeff Renaud, Senior Media Relations Officer, The
University of Western Ontario, 519-661-2111, ext. 85165,
jrenaud9@uwo.ca
Note to media: Western has a live television broadcast studio on
campus.
--
Truth resides in every human heart, and one has to search for it there, and to be guided by truth as one sees it. But no one has a right to coerce others to act according to his own view of truth. - Mohandas Gandhi
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