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Adjuvant Gives 70% Prevention of Infection in Primates
ATLANTA, GA, April 11, 2011- GeoVax Labs, Inc. (OTCBB:GOVX), announced today that
it is expanding its preventative HIV/AIDS vaccine development effort in collaboration with the National
Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH)
and the HIV Vaccine Trials Network (HVTN). Specifically, the HVTN plans to clinically test a novel
vaccine product developed by GeoVax scientists that expresses human granulocyte-macrophage colony
stimulating factor (GM-CSF) in combination with inactivated HIV proteins. The novel vaccine consists
of a recombinant DNA vaccine co-expressing human GM-CSF and non-infectious HIV virus-likeparticles.
The DNA vaccine is used to prime immune responses that are subsequently boosted by
vaccination with a recombinant modified vaccinia Ankara (MVA) vectored vaccine. The MVA expresses
the HIV virus-like-particles, but does not express GM-CSF. The regimen builds on the GeoVax
DNA/MVA vaccine that is currently in Phase 2a clinical testing through the HVTN.
GM-CSF is a cytokine (growth stimulating protein) that serves to expand and mature cells that initiate
immune responses and has undergone extensive testing in humans for cancer vaccines. The GM-CSFadjuvanted
vaccine was added to GeoVax's portfolio because of the outstanding ability of the simian
prototype vaccine to induce immune responses that prevented simian immunodeficiency virus (SIV)
infection. In nonhuman primates, the GM-CSF- enhanced vaccine achieved protection against SIV in
70% of the animals. Protection was measured against 12 weekly rectal challenges using a dose of SIV
which is estimated to be 30 to 300 times higher than the typical exposure dose of HIV in mucosal
transmission in humans.
"For years, the HIV vaccine field has been working with vaccines that elicited immune responses that
primarily controlled immunodeficiency virus challenges in infected animals, but did not actually prevent
infections. The ultimate goal is to prevent infections. The co-expression of GM-CSF with the SIV
proteins is a vaccine design that appears to be a large step towards reaching this goal," said Dr. Harriet
Robinson, Chief Scientific Officer at GeoVax. "In our trials in nonhuman primates, GM-CSF enhanced
the quality of the SIV-specific antibody response. Antibody is present in blood and tissues and has the
potential of blocking SIV before it infects cells. The GM-CSF-adjuvanted vaccine induced the
production of antibodies characterized with increased tightness of antibody binding. The tightness of
antibody binding, known as avidity, can be expressed as an index. Animals with indices above 40 were
protected from infection, whereas animals with lower indices were infected with the number of challenges
to infection correlating with their index."
"We are very pleased that the HVTN will be conducting trial HVTN 094 of our GM-CSF adjuvanted
vaccine product, which we expect will begin late this year," said Dr. Robert McNally, CEO of GeoVax.
"The HVTN, funded by the NIAID, is the largest worldwide clinical trials network dedicated to the
development and testing of HIV/AIDS vaccines. We are looking forward to working with an excellent
team of HVTN trial investigators.
About GeoVax Labs, Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV-1 (Human
Immunodeficiency Virus - AIDS) and other infectious agents. Our goals include developing AIDS
vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions
(FDA guidelines), conducting human trials for vaccine safety and effectiveness, and obtaining
regulatory approvals to move the product forward. All preventative phase 1 human clinical trials
conducted to date tested various combinations and doses of our DNA and MVA AIDS vaccines in
human volunteers for their demonstrated ability to raise anti-HIV immune responses as well as for their
safety. Successful results from all phase 1 testing supported the initiation of the first phase 2 testing.
GeoVax's phase 2 human trial began in January 2009 and will involve 225 participants at sites in the
United States and South America. Long term, we expect that GeoVax will grant manufacturing and
distribution rights in several global markets in return for upfront fees, collaborative development
agreements, and royalties on sales and distribution revenues. Internal vaccine manufacturing and
distribution will also be considered by GeoVax. For more information, please visit www.geovax.com.
About the HVTN
The HIV Vaccine Trials Network (HVTN) is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines.
The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to
testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The
Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The Network's headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
Forward-Looking Statements
Certain statements in this document are "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act. These statements are based on management's current expectations and are
subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in
these statements due to a variety of factors, including whether: GeoVax can develop and manufacture these
vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use,
GeoVax's vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals necessary
to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is
development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax
will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which
GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not
intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and
Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.
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Contact
The Investor Relations Group:
Investor Relations
James Carbonara
or
Public Relations
Janet Vasquez / Laura Colontrelle
(212) 825-3210
"Reproduced with permission - GeoVax Labs, Inc."
GeoVax Labs, Inc.
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