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GeoVax Announces Publication of Phase 1 Clinical Trial in The Journal of Infectious Diseases
Trial Results Establish Vaccine Safety and Immunogenicity
ATLANTA, Feb. 23, 2011 /PRNewswire/- GeoVax Labs, Inc. (OTCBB:GOVX), announced today the publication of the results of Phase 1 clinical trial testing of its HIV/AIDS vaccine products. The article, titled "Phase 1 Safety and Immunogenicity Testing of
DNA and Recombinant Modified Vaccinia Ankara Vaccines Expressing HIV-1 Virus-like Particles," will appear in the March 1 issue of The Journal of Infectious Diseases. A PDF of the article is available at the following URL: http://jid.oxfordjournals.org/cgi/reprint/jiq105?ijkey=n
T44dx1yCxsiOjV&keytype=ref.
GeoVax is developing two vaccine components: a recombinant DNA-vectored vaccine; and a recombinant MVA-vectored vaccine. Both produce non-infectious virus-like particles in the body of a vaccine recipient. These non-infectious particles are designed to "train" the immune system of the vaccinated person
to recognize HIV should the vaccinated person be exposed to the real virus. Both the DNA and MVA vaccines induce humoral (antibody) and cellular (T cell) responses. Antibodies have the potential to block virus before it infects cells. The T cells have the potential to recognize and kill cells that become infected by virus that gets past the antibody.
The publication reports the results of three different trial regimens: (1) priming with two doses of the pGA2/JS7 recombinant DNA vaccine and boosting with two doses of MVA/HIV62B recombinant MVA vaccine (DDMM regimen); (2) priming with one dose of the recombinant DNA and boosting with two doses of the recombinant
MVA (DMM regimen); and (3) priming and boosting with a total of three doses of the recombinant MVA vaccine (MMM regimen). The Phase 1 trial, initiated in 2006 and completed in 2009, included 120 participants, was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health,
and was conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN). Support for the development of both DNA and MVA vaccines was also received from NIAID.
The vaccines showed excellent safety characteristics in each of the three regimens. All of the regimens induced both antibody and T cell responses. Antibody-induced immune response rates were highest in the MMM group, whereas T cell response rates were highest in the DDMM group. The DMM group had intermediate response rates. "We are encouraged with the results seen in this trial, as the vaccine is safe and is able to induce a wide variety of immune responses directed against HIV," notes Dr. Paul A. Goepfert, the study's lead investigator.
On the basis of the excellent safety and immune response rates, HVTN has moved both the DDMM and MMM regimens forward into Phase 2a testing, which is currently ongoing in the trial designated HVTN 205. HVTN 205 has 300 participants in both North and South America and is designed to increase the base of information on safety and immunogenicity.
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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