ATLANTA, Dec. 6, 2010 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), announced today the expansion of the Phase 2a clinical trial testing of its HIV/AIDS vaccine products. The expanded Phase 2a trial will test the administration of three doses of the recombinant poxvirus vaccine MVA62B without the use of the recombinant DNA-vectored vaccine, which was used to prime immune responses in the first part of this trial. At the completion of the trial, 150 participants will have received the vaccine products using two DNA inoculations followed by two MVA inoculations, 75 participants will have received the vaccine using three MVA inoculations and 75 participants will have received placebo. Enrollment into the expanded Phase 2a trial opened December 6th.
GeoVax is developing two vaccine components: a recombinant DNA-vectored vaccine and a recombinant MVA-vectored vaccine. Both produce non-infectious virus-like particles in the body of a vaccine recipient. These non-infectious particles are designed to "train" the immune system of the vaccinated person to recognize HIV should the vaccinated person be exposed to the real virus. Both the DNA and MVA vaccines induce humoral (antibody) and cellular (cytotoxic T cell) responses. Antibodies have the potential to block virus before it infects cells. The cytotoxic T cells have the potential to recognize and kill virus-infected cells. The vaccine is designed to control clade B HIV infections. Clade B HIV is found in North, Central and parts of South America, Western Europe, Australia and Japan.
"I like the simplicity of using the MVA-vectored vaccine alone because it is a regimen that could easily be taken forward for the world. The data from our Phase 1 clinical trial and recent preclinical data obtained using a non-human primate model support the use of this simplified vaccine regimen," said Harriet Robinson, the GeoVax Chief Scientific Officer.
The expanded Phase 2a trial is sponsored by the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health, and is conducted by the HIV Vaccine Trials Network (HVTN). The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. The trial bears the same HVTN 205 designation as the original Phase 2a trial.
About GeoVax Labs, Inc.
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. 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. For more information, please visit www.geovax.com.
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.
At The Investor Relations Group:
Janet Vasquez / Robin O'Malley
SOURCE GeoVax Labs, Inc.