Expansion of HIV/AIDS Vaccine Program Announced by GeoVax Labs, Inc.

/PRNewswire/ -- GeoVax Labs, Inc. (OTCQB/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-like-particles. 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-CSF-adjuvanted 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."

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GeoVax's Phase 2a HIV/AIDS Vaccine Human Trials to Begin in North and South America

/PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC:GOVX) (BULLETIN BOARD: GOVX) , an Atlanta-based biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, announced today that the launch of its Phase 2a Human Vaccine Trials will take place in twelve sites across North and South America. These trials are conducted in collaboration with The National Institutes of Health (NIH), and the HIV Vaccine Trials Network (HVTN).

"It is of significant importance to report this major development on this very day in which the world commemorates WORLD AIDS DAY. Despite setbacks reported recently with other vaccine trials, our vaccine is progressing and paving the way for a solution that would potentially make this commemorative day more joyful," commented Dr. Robert McNally, GeoVax's President and CEO.

Dr. Harriet Robinson, Vice President of Research and Development of GeoVax Labs, Inc., stated, "We feel privileged to be in the position to launch our Phase 2a human trial. Going forward, each clinical site's review board will start the vaccination process, when deemed appropriate and ready. Accordingly, HVTN's pharmacy will release the vaccines to each designated institution as directed by each site's local review board."

Trial site arrangements and other details of the study were confirmed in a recent meeting held in Seattle, Washington, between the HVTN and GeoVax's scientific personnel. The Phase 2a human clinical trial will involve 150 vaccinees and 75 placebo (control) participants. The vaccine regimen employs a two-component "prime-boost strategy." Trial participants will first be administered a GeoVax HIV-1 DNA vaccine which "primes" the immune system followed by the second vaccine, GeoVax's HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines express the three major proteins of the AIDS virus. These proteins mimic more than 50% of the components of the AIDS virus (HIV-1) but cannot cause AIDS. GeoVax AIDS vaccines are designed to prevent HIV-1 virus infection which causes Acquired Immunodeficiency Disease (AIDS).

The Seattle meeting also achieved further progress with GeoVax's therapeutic trial. Information on this and other developments will be reported in a timely fashion in the near future.

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