GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today the opening of a second clinical trial site at the Alabama Vaccine Research Clinic (AVRC) of the University of Alabama at Birmingham (UAB) to expand the company's HIV therapeutic vaccine trial. Although the GeoVax vaccines are currently being tested clinically for HIV prevention, this is the first clinical trial using the same products for treatment of persons who already have HIV infection. UAB joins the AIDS Research Consortium of Atlanta (ARCA) as the second site used for this trial.
"We are very pleased to be expanding this important clinical trial to include the AVRC, a group with which we have worked successfully for several years," noted Mark Newman, PhD, Vice President of Research and Development at GeoVax.
Sonya Heath, MD, the medical director for the study at UAB, said, "New approaches to HIV treatment are critically needed, and an effective therapeutic vaccine would be an important tool in our ongoing efforts to treat people with HIV infection. A vaccine that enhances the body's ability to control HIV and decreases the dependence on antiretroviral drugs would be a major breakthrough."
To be eligible for the study, potential volunteers need to be diagnosed within the first year of HIV infection and they must have started antiretroviral drug therapy within six months of diagnosis. The study will last up to 77 weeks for each participant. All patients will be followed closely to assess vaccine safety and for the ability of the vaccine to induce therapeutic immune responses. Only 10 to 12 persons will be selected to participate.
About The Alabama Vaccine Research Center
The AVRC, established in 1994, is one of 10 National Institutes of Health (NIH)-sponsored HIV Vaccine Trials Units in the US. The medical staff of the AVRC conducts Phase 1, Phase 2, and Phase 3 clinical trials of experimental HIV vaccines. The goals of these clinical research studies are to evaluate the safety and the ability of new vaccines to induce immune responses capable of protecting individuals from HIV infection and/or controlling disease. The AVRC has contributed to the clinical testing of the GeoVax HIV vaccines in HIV uninfected individuals.
Dr. Harriet L. Robinson, Senior Vice President for Research and Development at GeoVax Inc., a biotech company specializing in the development of HIV/AIDS vaccines
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV (Human Immunodeficiency Virus – that leads to AIDS) and other infectious agents. 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. GeoVax's Phase 2 human trial began in January 2009 and will ultimately involve 300 participants at sites in the United States and South America. Recently GeoVax began enrolling patients in a Phase 1 therapeutic trial for individuals already infected with HIV.
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its 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, GeoVax will be able to enter into favorable manufacturing and distribution agreements, 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. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.
The Investor Relations Group
Janet Vasquez or Robin O'Malley