ATLANTA, Aug. 5 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based HIV/AIDS vaccine development company, today announced updates on its ongoing and planned human clinical trials.
"We have two main areas of focus for our HIV/AIDS vaccine - preventative and therapeutic," stated Robert McNally, Ph.D., Chief Executive Officer and President of GeoVax Labs, Inc. "The results of the early Phase 1 clinical work for the preventative version of the vaccine have allowed the company to move up to another level of analysis, Phase 2a human clinical trial. This trial was initiated by the HIV Vaccine Trials Network (HVTN) in February this year and we are pleased to report that the HVTN has currently enrolled 30% of the projected participants. On the therapeutic front, we are in the midst of planning the details of a Phase 1 human clinical trial and expect to begin this trial, assuming FDA approval, in the first quarter of 2010."
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.
The trial is still expected to include a total of 225 volunteers (150 vaccine recipients and 75 placebo recipients) and take place at 13 HVTN sites: 11 in North America and two in South America. Sites in the United States include Emory University, Atlanta; Harvard Medical School, Boston; Vanderbilt University, Nashville; University of Rochester; Fred Hutchinson Cancer Research Center, Seattle; the San Francisco Department of Public Health; University of Alabama, Birmingham and sites at Columbia University, Union Square, and the Bronx in New York City. In South America, participants are to be enrolled in Peru at sites in Iquitos and Miraflores (Lima).
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.
He continued, "You will recall that trials conducted using a simian immunodeficiency virus (SIV) prototype of the GeoVax HIV vaccine in SIV-infected primate animal models have held high promise that the GeoVax vaccine will be able to contribute to the control of HIV-1 in already infected humans. Our team is working hard to develop the clinical trial protocol and to assemble all the information required for an FDA submission seeking approval to move forward with the clinical trial. We plan to submit our package to the FDA in the very near future."
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.
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.
"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."
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 HIV).
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.
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 a $17 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: 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.
For more information on GeoVax Labs, Inc., please visit the Company's website at www.geovax.com
|SOURCE GeoVax Labs, Inc.|
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