ATLANTA, Aug. 5 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. , an Atlanta-based HIV/AIDS vaccine development company, today announced updates on its ongoing and planned human clinical trials.
Preventative Clinical Trials - Phase 2a
The preventative trial, designated as HVTN 205, is being conducted by the 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 is a significant step for GeoVax. The first injections for the Phase 2a trial were conducted at the HVTN network sites at the University of Alabama, Birmingham, and Vanderbilt University, Nashville.
Therapeutic Clinical Trials - Planning for Phase 1
To help serve those people who are already infected with HIV, the Company is preparing for a Phase 1 therapeutic trial to start in early 2010. “The goal here is to reduce the need for anti-viral drugs. This initial trial will determine the safety and immunogenicity of the vaccine in patients with well controlled infections who started on drugs within six months of testing positive for HIV,” stated McNally.
The initial therapeutic trial will be conducted locally in Atlanta. This first step will be a safety trial using intensive monitoring to verify the ultimate safety of the vaccine.
“Vaccine trials can be a slow process,” said Harriet Robinson, Ph.D., developer of the vaccine and Senior V.P. of Research and Development. “The therapeutic trials should move more rapidly than the preventative trials because each participant provides not only endpoints for safety and immunogenicity, but also an endpoint for protective efficacy. But, before these trials can scale up, we need to demonstrate safety for our participants in both vaccination and subsequent phases of therapeutic studies. We have safety and efficacy data for non-human primates. The next step is determining safety in a small trial of intensively monitored humans.”
GeoVax’s core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Senior V.P. of Research and Development, 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.
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.
SOURCE GeoVax Labs, Inc.
CONTACT: Robert McNally of GeoVax Labs, Inc., +1-404-727-0971,
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/
