Human clinical trials of HIV/AIDS vaccine making steady progress
By Communications Staff
November 06, 2012
London, Ontario CANADA - The first and only preventative HIV vaccine based on a genetically modified
killed whole-virus has been making steady progress in Phase I Clinical Trials in the United States and the interim results are being
analyzed in preparation for the next steps.
Developed by Dr. Chil-Yong Kang and his team at Western University's Schulich School of Medicine & Dentistry, with the
support of Sumagen Canada, the vaccine (SAV001-H) holds tremendous promise for success in the final phases of clinical testing now
that the first hurdle has been accomplished. It is the only HIV vaccine currently under development in Canada, and one of only a
few in the world. The first human applied clinical study (SAV CT 01) using a genetically modified killed whole-virus vaccine
(SAV001-H) to evaluate its safety and tolerability was initiated in March 2012. This study is a randomized,
observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine (SAV001-H) following
intramuscular (IM) administration. Infected men and women, 18 to 50 years of age, have been
enrolled in this study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or placebo.
Sumagen announced today that the patient enrollment has progressed smoothly and there have been no adverse effects
observed including local reactions, signs/symptoms and laboratory toxicities after SAV001-H injection in all enrolled
patients to date. With these interim results, the SAV001-H has proven safety and tolerability in humans and given
Sumagen confidence for the next clinical trials to prove its immunogenicity and efficacy evaluation.
In addition, the humoral immune responses, such as HIV-1 antibody formation against SAV001-H, are currently
being analyzed. The interim data showed significant increase in the HIV-1 antibody formations after SAV001-H
administration compared to the base line in some patients. Even though this study is a blinded study until
completion, these results are encouraging for the possibility of the prophylactic potency of SAV001-H.
With these interim results, Sumagen is confident of the safety of SAV001-H and the potency of inducing immune
responses in human trials.
Dr. Dong Joon Kim, a spokesperson for Sumagen Co. Ltd. says, "We have proven that there is no safety concern
of SAV001-H in human administration and we are now prepared to take the next steps towards Phase II and Phase
III clinical trials. We are delighted to be one step closer to the first commercialized HIV vaccine."
In future, the company will be looking for collaboration with multi-national biopharmaceutical companies for
globalizing clinical trials and commercialization.
This Phase I clinical trial (SAV CT 01) was partially funded by Industrial Research Assistant Program of National
Research Council Canada since January 2012.
HIV/AIDS has killed more than 28 million people worldwide, and more than 34 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 vaccine has been commercialized 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.
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 Western University
Western delivers an academic experience second to none. Since 1878, The Western Experience has combined academic
excellence with life-long opportunities for intellectual, social and cultural growth in order to better serve our
communities. Our research excellence expands knowledge and drives discovery with real-world application. Western
attracts individuals with a broad worldview, seeking to study, influence and lead in the international community.
Media contact: Jeff Renaud, Senior Media Relations Officer, Western University: 519-661-2111,
ext. 85165 (office); 519-520-7281 (cell); email@example.com
Note to media:
Western has a live television broadcast studio on campus. To coordinate interviews, please call 519-661-2111, ext. 85165.
Source: Western University
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