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GeoVax Labs, Inc. Begins Enrollment at Final Site for Preventative Vaccine; Next Step Is to Submit IND Application for Therapeutic Vaccine to FDA
Date:2/8/2010

s="xn-location">Peru," commented Dr. McNally.

The preventative trial, designated as HVTN 205, is being conducted by the HIV Vaccine Trials Network (HVTN). The HVTN, funded and supported by the National Institutes of Allergy and Infectious Diseases (NIAID), is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. The HVTN has sponsored over 80 Phase 1 trials for the initial evaluation of safety and immunogenicity of candidate HIV/AIDS vaccines. The results of these trials have merited only five Phase 2 trials. Progressing to Phase 2 was a significant step for GeoVax.

Therapeutic Clinical Trials – Preparing for Phase 1

To help serve those people who are already infected with HIV, the Company is testing its vaccine for the ability to supplant the need for drugs in HIV-positive individuals. Antiretroviral drugs, which have to be taken for life, have side effects and are expensive, costing on average $18,000 per year. GeoVax is currently preparing an Investigational New Drug application (IND) for its Phase 1 therapeutic trial for the FDA. Following receipt of the IND, the FDA has 30 days to respond. If there are no FDA concerns, the company can begin the trial.  

This initial trial will be conducted in Atlanta and enroll individuals who began successful antiretroviral therapy within the first year of infection. The goal of this trial is to determine the safety and immunogenicity of the vaccine in patients with well-controlled infections who started on antiretroviral therapy drugs within six months of testing positive for HIV.

"Based on the success of the simian prototype of the GeoVax vaccine in controlling established infections in the non-human primate model, we believe our vaccine should be effective in at least some infected humans," said Dr.

SOURCE GeoVax Labs, Inc.
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