GeoVax Labs' First Patient Inoculated in Phase 1/2 Clinical Trial for HIV/AIDS Therapeutic Vaccine
Important Milestone in Study of HIV-Infected Individuals Who Started Drug Treatment During Their First 18 Months of Infection
ATLANTA, Dec. 13, 2011 /PRNewswire/ -- GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), an Atlanta-based biopharmaceutical firm ("the Company") developing vaccines that prevent and fight Human Immunodeficiency Virus (HIV) infections, announced that the first patient has been inoculated in the Phase 1/2 clinical trial for the Company's HIV/AIDS therapeutic vaccine. This is the first study using GeoVax Labs' vaccines for the treatment of persons who are HIV infected.
The protocol for the Phase 1/2 clinical trial will carefully monitor safety while evaluating the ability of the vaccine to elicit protective immune responses in vaccinated participants. The trial is based on the achievement of post-vaccine viral control in animal studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University.
Robert McNally, Ph.D., President and CEO of GeoVax Labs, stated, "Dosing the first study participant marks a major milestone for our Phase 1/2 clinical trial. We are pleased to have the AIDS Research Consortium of Atlanta, the Alabama Vaccine Research Center at the University of Alabama, Birmingham, and the AIDS Research Alliance of Los Angeles participating in the trial. These three trial sites are actively seeking persons who are interested in and fit the criteria for the study."
To be eligible for the study, persons should have started drugs within 18 months of their last HIV negative test. Persons who have been infected within the past 18 months, but not started drugs, are also eligible for recruitment into the study. The first participant was enrolled at the AIDS Research Consortium of Atlanta.
About GeoVax Labs, Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV. Our goals include developing HIV/AIDS vaccines for global markets, overseeing the manufacture and testing of these vaccines under GMP/GLP conditions (FDA guidelines), conducting clinical trials for vaccine safety and effectiveness, and obtaining regulatory approvals to move the product forward. GeoVax's vaccines are unique in expressing virus like particles that display the trimeric membrane bound form of the HIV-1 envelope glycoprotein. All preventative Phase 1 human clinical trials conducted to date tested various combinations and doses of our DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as well as, the vaccines' safety. Successful results from Phase 1 testing supported the initiation of the first Phase 2 testing, which is now completely enrolled. The phase 2 trial involves 300 participants at sites in the United States and South America. GeoVax is also enrolling patients in a Phase 1/2 therapeutic trial for individuals already infected with HIV. For more information, please visit www.geovax.com.