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GeoVax Labs, Inc. Reports Data on Prototype Adjuvant - Supplemented HIV Vaccine Tested in Preclinical Animal Studies

Results From Study Using Non-human Primates Indicate 70% Level of Protection From Infection Presentation Made at Conference on Retroviruses and Opportunistic Infections

ATLANTA, Feb. 18 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical company developing vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus), today announced that it presented the results of a preclinical study on a prototype HIV/AIDS vaccine at the Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.

The oral presentation, "Preclinical Studies on DNA/MVA Vaccines: Co-expressed GM-CSF, a Strong Adjuvant for Prevention of Infection," was presented by Dr. Harriet Robinson, Chief Scientific Officer for GeoVax and developer of the Company's vaccines. The study investigated the use of GM-CSF (granulocyte/macrophage colony-stimulating factor) as an adjuvant with the DNA prime for the GeoVax DNA/MVA vaccine for prevention of HIV/AIDS.

Adjuvants are agents that can increase the potency and effectiveness of a vaccine. GeoVax's work on adjuvants started in 2007. At that time, the National Institutes of Health (NIH) granted the company $15 million over five years to fund the search for any benefit derived from the use of adjuvants. Results using GM-CSF showed protection from infection from simian immunodeficiency virus (SIV-monkey version of the HIV virus) in 70% of the seven exposed animals after 12 weekly exposures to the SIV virus.

"This is the highest level for prevention of an immunodeficiency virus infection ever reported in a non-human primate model," said Dr. Robinson. "We and other scientists originally thought it very difficult, even impossible, to completely prevent SIV infections. But based on the results from this study, we are now hopeful that our DNA/MVA vaccine supplemented with GM-CSF could actually prevent, not just control, HIV infections in humans."

The GM-CSF results were produced in a study using repeated rectal challenges with a dose of SIV that is 40 to 400 times the estimated typical dose of HIV associated with infections in humans. Following 12 weekly infection attempts, all nine of the unvaccinated animals became infected, whereas only two of the seven animals vaccinated with the adjuvant-supplemented vaccine became infected.

"An ideal vaccine does not need an adjuvant and our vaccine currently in Phase 2a testing for prevention of HIV/AIDS does not contain one. However, with this recent success, we believe we have the data needed to support the design of an alternative HIV vaccine for GeoVax's product pipeline if our current vaccine does not provide good success," added Dr. Robinson.

GeoVax's mission is to develop both a preventative and therapeutic vaccine to combat HIV/AIDS. Robert McNally, Ph.D., President and Chief Executive Officer, explained, "We are currently in a Phase 2a clinical trial with a vaccine that proved safe and immunogenic in Phase 1 testing. We are and continue to be optimistic about this product. The results from the adjuvant-supplemented product test suggest that we may have an effective alternative product should our non-adjuvanted vaccine prove suboptimal in expanded human clinical trials. This vaccine is being added to the patent portfolio of the company."

The work identifying the adjuvant activity of GM-CSF is supported by an NIH funded Integrated Preclinical/Clinical AIDS Vaccine Development program. Animal studies were completed at the Yerkes Primate Research Center in close collaboration with Drs. Lilin Lai and Rama Rao Amara. Investigators at Louisiana State University and Duke University also participated in the project.

About CROI

The 17th Conference on Retroviruses and Opportunistic Infections (CROI 2010) is a scientifically focused meeting of the world's leading researchers working to understand, prevent, and treat HIV/AIDS and its complications.

The subjects that will be highlighted are: virology (including HIV and all other retroviruses), molecular epidemiology (including distribution and diversity of retroviruses), HIV immunology, pathogenesis of HIV-mediated Immunodeficiency, neuropathogenesis and neurologic complications, HIV transmission and primary/acute infection, preventive HIV vaccines (including preclinical candidates and clinical trials), therapeutic HIV vaccines and immune-based therapies (including cytokines), human genomics, antiretroviral therapy (preclinical, randomized clinical trials, observational studies, and complications), HIV drug resistance (including molecular mechanisms, pathogenesis, clinical implications, epidemiology, and resistance diagnostics), clinical pharmacology, complications of HIV infection, opportunistic infections (including basic science, immunology, pathogenesis, epidemiology, and other clinical studies), hepatitis virus co-infections, AIDS-related malignancies, pediatrics/adolescents, maternal/fetal, HIV in women/women's health, novel diagnostic technologies and new monitoring tools, epidemiology of HIV infection, sexually transmitted infections (non-HIV including basic science, immunology, pathogenesis, epidemiology, and other clinical studies), prevention studies (including 0, pre-exposure prophylaxis, circumcision, and behavioral interventions), and research on delivery of care in developing countries (including operational research and implementation).

CROI 2010 will present and debate controversial scientific issues, several hundred original oral abstract and poster presentations of new data, and late breakers that will consist of important preliminary research findings.

The Technology

GeoVax's unique two component vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV T cell and anti-HIV antibody immune responses. Stimulation of both T cells and antibodies differentiates the GeoVax vaccine from many other vaccine candidates. GeoVax's DNA and MVA vaccines are used in a prime-boost protocol in which priming is done with the DNA and boosting with the MVA. Both the DNA and MVA express the three major proteins of the AIDS virus: Gag, Pol, and Env, and produce non-infectious virus-like-particles. These particles contain proteins that mimic more than half of the components of the AIDS virus, but cannot cause AIDS. This multi-protein approach is designed to elicit a broad multi-target protective T cell response. The Env protein is designed to elicit a protective antibody response against the natural form of the virus envelope glycoprotein as well as protective T cells.

About HIV/AIDS

AIDS is an epidemic that can affect anyone, regardless of race, gender, age or sexual orientation. 33 million people are currently infected globally and it is estimated that there will be 2.5 million new infections this year. Since the beginning of the epidemic, over a million people in the U.S. have contracted the virus. Every 9 1/2 minutes, someone in the U.S. is infected with AIDS. Globally, HIV is the top killer among women of reproductive age.

HIV is a worldwide disease with different subtypes (or clades) of the virus predominating in different regions of the world. Clade B is the predominant subtype in North America. Globally, most infections involve subtypes AG, B, and C. In 2008, antiretroviral treatment in low and middle income countries was restricted to about 3 million people. In the United States, about 50% of those who are infected are estimated to be on drug treatment.

About GeoVax Labs, Inc.

GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus). GeoVax's AIDS vaccine technology is the subject of 20 issued or filed patent applications. GeoVax AIDS vaccines are designed for use in uninfected people to prevent acquisition of HIV-1 and limit the progression to AIDS should a person become infected. GeoVax AIDS vaccines also may be effective as a therapeutic treatment (for people already infected with the HIV-1 virus).

GeoVax's core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Chief Scientific Officer, through a collaboration of colleagues at Emory University's Vaccine Center, the National Institutes of Health (NIH), The Centers for Disease Control and Prevention (CDC) and GeoVax.

GeoVax's AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of AIDS vaccines. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided additional support to GeoVax AIDS vaccine development program with an $18 million IPCAVD grant awarded in late 2007.

Safe Harbor Statement

All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions on the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Risks and uncertainties include, but are not limited to, whether: the results of this study are supported by further research, the results demonstrated in the animal studies with SIV are also obtained in humans with HIV, 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, 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. Certain matters discussed in this news release are forward-looking statements involving certain risks and uncertainties including, without limitation, risks detailed in the Company's Securities and Exchange Commission filings and reports.

Source: GeoVax Labs, Inc.

CONTACT: Robert McNally of GeoVax Labs, Inc., +1-678-384-7220,
rmcnally@geovax.com; or Leslie Loyet, Investor Relations, +1-312-640-6672,
lloyet@mww.com, or Nikki Snodgrass, Media Relations, +1-312-640-6732,
nsnodgrass@mww.com, both of Financial Relations Board, for GeoVax Labs, Inc.

Web Site: http://www.geovax.com/

 

Posted: February 2010

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