Excellent Safety and Reproducible Immunogenocity Demonstrated in Early Results of Phase 2a Trial for Hiv Preventative Vaccine
ATLANTA – December 9, 2010 – GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX) (the “Company”), announced today that early results from part A of an ongoing phase 2a clinical trial indicate an excellent safety profile and highly reproducible immunogenicity. The phase 2a trial is testing two recombinant DNA-vectored vaccine inoculations; the first at week 0 and the second at week 8, followed by two recombinant MVA-vectored vaccine inoculations, at weeks 16 and 24. The still-blinded data for 180 trial participants, enrolled at a ratio of two vaccine recipients for each placebo, reveal no safety concerns. These results are very similar to those observed in the Phase 1 trial. The trial, designated HVTN 205, is being conducted by the HIV Vaccine Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health.
Of particular interest are assay results measuring vaccine-induced cellular (T-cell) immune responses, which are available for 128 of the participants. These tests revealed cellular immune response rates similar to those observed in the Phase 1 trial. Additional testing is ongoing to measure antibody responses and to further characterize cellular immune responses. Data will continue to be accumulated as the trial is completed.
“The high level of safety was expected” said Dr. Harriet Robinson, Chief Scientific Officer of GeoVax, “because of the excellent tolerability of recombinant DNA and recombinant MVA vaccine vectors in humans in our, as well as other prior trials. The apparent reproducibility of vaccine immunogenicity is very encouraging. The immunogenicity data not only indicate that our vaccine products are functioning as designed but also demonstrate the capabilities of the central HVTN laboratory whose scientists have developed and validated the assays that are so critical to clinical vaccine testing.” About GeoVax Labs, Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV (Human Immunodeficiency Virus – that leads to AIDS). Our goals include developing HIV/AIDS vaccines for global markets, overseeing the manufacture and testing 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 were designed to test combinations and dose levels of our DNA and MVA vectored vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (CD4+ helper and CD8+ 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.
### Forward-Looking Statements 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.
Contact At The Investor Relations Group: Investor Relations
James Carbonara or Public Relations Janet Vasquez / Robin
O’Malley (212) 825-3210
Posted: December 2010