ATLANTA, March 12, 2012 /PRNewswire/ -- GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), an Atlanta – based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, announced receipt of an "Allowed to Proceed" notice from the U.S. Food and Drug Administration (FDA) for human clinical testing of its granulocyte-macrophage colony stimulating factor (GM-CSF) -adjuvanted DNA/MVA vaccine. The Phase 1 trial is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and will be conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN) under protocol HVTN 094.
GeoVax's current HIV/AIDS vaccine consists of DNA priming and MVA boosting. The GM-CSF adjuvant, an additive aimed to potentially increase efficacy, is co-expressed in the DNA but not the MVA components of the current vaccine regimen. In preclinical non-human primate studies, co-expression of GM-CSF in a simian prototype of the DNA vaccine improved the ability of the vaccine to prevent infection. Vaccinating in the presence of co-expressed GM-CSF achieved a 87% reduction in the per exposure risk of transmission, in a study employing 12 successive weekly exposures to simian immunodeficiency virus, the primate version of HIV, whereas vaccinating in the absence of the co-expressed GM-CSF achieved a less effective 60% reduction in the per exposure risk of transmission. The primary goals for the clinical trial will be to assess the safety of the adjuvant when it is co-expressed by the DNA priming vaccine and to evaluate the immune response to the adjuvanted vaccine. Typically, when tested in healthy adults, GM-CSF stimulates the expansion and differentiation of cells in the macrophage and dendritic cell lineages that initiate immune responses. The use of GM-CSF in humans as an adjuvant for an HIV vaccine is anticipated to have a good safety profile, given that it is already licensed to stimulate production of white blood cells after autologous bone marrow transplantation, is approved as a treatment for fungal infections as well as an adjuvant for the Provenge® prostate cancer vaccine.
"Enhancing the ability of an HIV vaccine to prevent infection is critically important to the development of an HIV/AIDS vaccine," said Harriet Robinson, Ph.D., GeoVax's Chief Scientific Officer and developer of the vaccine. "HIV is a chronic infection that survives by being able to evade the defenses of its host. If the infection is prevented from the beginning, the virus never has the chance to embed itself in the host."
"Considering the previous safety data on the DNA and MVA vaccines, the successful completion of this trial may allow us to proceed directly to a 'ramp-in' Phase 2b efficacy trial, which we are already planning," said Robert McNally, Ph.D., GeoVax's President and CEO.
The HVTN 094 trial will be conducted at HVTN sites at the San Francisco Department of Public Health, the University of Rochester, The Alabama Vaccine Center in Birmingham, and Brigham and Women's Hospital in Boston. The trial is expected to open in April.
The development and production of the GM-CSF co-expressing DNA vaccine and its MVA vaccine boost have been funded by a cooperative agreement between NIAID and the Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD).
About GeoVax Labs, Inc.
GeoVax is a biotechnology company developing human vaccines for HIV/AIDS. 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 GeoVax 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 Phase 2 testing in an ongoing, fully enrolled, 300 participant trial in North and South America. The vaccine is also undergoing Phase 1 /2 testing as a therapeutic in HIV-infected individuals.
About the HVTN
The HIV Vaccine Trials Network (HVTN) is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The Network's headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
NIAID conducts and supports research—at NIH, throughout the United States and worldwide—to study the causes of infections and immune-mediated diseases, and to develop better means of preventing, diagnosing, and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.
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.
Erika Moran, Investor Relations
Janet Vasquez, Public Relations
SOURCE GeoVax Labs, Inc.