ATLANTA, GA -- (Marketwire) -- 09/26/12 -- GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing vaccines to prevent and fight HIV/AIDS, was featured in several presentations at the AIDS Vaccine 2012 Conference in Boston, September 10-12. The HIV Vaccine Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, reported results of the GeoVax Phase 2a trial as well as comparative immunogenicity data from a series of HVTN trials of different candidate vaccines.
Paul A. Goepfert, MD, University of Alabama in Birmingham, Protocol Chair, reported safety and immunogenicity data for the HVTN 205 Phase 2a trial of the GeoVax vaccine candidates. HVTN 205 was undertaken in 300 participants to further compare full-dose regimens of DNA priming and modified vaccinia Ankara (MVA) boosting (DDMM regimen) with MVA priming and boosting (MMM regimen). Both vaccine regimens appeared safe and well-tolerated. Similar to Phase 1 testing, the GeoVax "DDMM regimen" induced higher rates of T cell responses whereas the "MMM regimen" induced higher rates of antibody responses. Antibody responses to Env were seen in more than 90 percent of both groups. The Phase 2a trial confirmed Phase 1 results, setting the stage for Phase 2b efficacy trials. The Phase 2b trial will test GeoVax's second-generation product that co-expresses HIV proteins and granulocyte-macrophage colony-stimulating factor in the DNA prime.
Nicole Frahm, Ph.D., Associate Laboratory Director, HVTN Laboratory in Seattle, compared immune responses elicited by vaccines developed by GeoVax to those by Therion Biologics Corp.and the South African AIDS Vaccine Initiative. All of these vaccines used DNA priming and poxvirus boosting or poxvirus priming and boosting. These studies compared DNA, MVA and fowlpox vectors. The results showed the GeoVax vaccines performed well in all categories of tested responses. The GeoVax MVA vaccine performed particularly well in the elicitation of neutralizing antibody for both Tier 1 (easy to neutralize) and Tier 2 (more difficult to neutralize) isolates of HIV.
Harriet L. Robinson, Ph.D., GeoVax's Chief Scientific Officer, presented data reviewing a long-term protection study (currently at four years) in which rhesus macaques vaccinated with simian homologs of the GeoVax second-generation vaccines were subjected to 43 independent rectal exposures to virus. At the 43rd challenge, the last two uninfected macaques in the study became infected. Combined with the consistency and quality of safety and immune responses for the first-generation vaccines in HVTN-sponsored clinical trials, the success of this long-term challenge study provides the rationale for proceeding with the second generation "GM-CSF co-expressing product" into Phase 2b human efficacy trials.
"We are very pleased with the ongoing progress and encouraging results resulting from both our clinical and preclinical studies," said David A. Dodd, GeoVax's Chairman. "The HVTN has very effectively proceeded with our GM-CSF co-expressing product into the clinic in HVTN 094. This Phase 1 study, which will provide safety and immunogenicity data for our 2nd generation product and support our progress into Phase 2b, is enrolling more rapidly than anticipated."
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