GeoVax's Phase 2a HIV/AIDS Vaccine Human Trials To Begin In North And South America

Main Category: HIV / AIDS
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 02 Dec 2008 - 0:00 PST

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GeoVax Labs, Inc. (OTC 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.

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) and other infectious agents. 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 Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should the person ever become infected. GeoVax AIDS vaccines also may be effective as therapeutics (treatment of people already infected with the HIV-1 virus). Studies evaluating these vaccines in HIV/AIDS infected individuals are in the planning stage.

GeoVax's core AIDS vaccine technologies were developed 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 the GeoVax team.

GeoVax 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 a $15 million IPCAVD grant awarded in late 2007. http://www.geovax.com

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: 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.

GeoVax Labs, Inc.
http://www.geovax.com